In a memo dated May 30, 2023, NLRB General Counsel Jennifer Abruzzo informed all regional directors, officers-in-charge, and resident officers that non-compete agreements impede the ability of employees to exercise …
More women are on the company's payroll than recorded in recent history. Millions of women lost their jobs or left the workforce during the early pandemic. The pandemic had a …
On May 15th, 2023, the US Equal Employment Opportunity Commission (EEOC) issued a number of significant revisions to its COVID-19 standards."The end of Public Health Emergency is an important …
The United States Department of Homeland Security (DHS) and Immigration and Customs Enforcement (ICE) stated on May first week that when the COVID-19 flexibilities expire on July 31, 2023, companies …
International Bussiness Machines Corp. (IBM) expects to halt hiring for roles that could be replaced by artificial intelligence in the near future. During an interview with Bloomberg IBM CEO Arvind …
On September 9, 2021, The White House announced a COVID-19 plan that includes a comprehensive national strategy to address rising COVID-19 cases from the delta variant.Biden imposed strict …
IRCA requires employers in the United States to complete Form I-9 for all new hires in order to ascertain their identity to work in the country. Both employers and employees …
The Biden administration announced that U.S. Citizens who have been fully vaccinated with a two-dose COVID-19 regimen should receive a booster, referring to the threat of the highly contagious Delta …
On August 23, 2021, the U.S. Food and Drug Administration fully approved the Pfizer Inc. COVID-19 vaccine for people over 16 years of age. The vaccine has been licensed for …
Many people with COVID-19 get better within weeks, some people continue to experience symptoms that can last months after first being infected, or may have new or recurring symptoms at …
DOL Issues Guidance on COVID-19 Claims Handling under LHWCASeveral questions have arisen on how to make claims and handle worker compensation claims arising from COVID under the LHWCA. …
EEO-1 Portal To Open April 26, Deadline For Filing Will Be July 19, 2021The Us Equal Employment Opportunity Commission finally announced the opening date for the collection of …
California Governor Gavin Newsom signed SB 95 legislation reestablishing statewide supplemental paid sick leave for reasons related to COVID-19 and expanding the covered reasons that qualify an employee for the …
The Department of Labor released its report on new jobless claims on Thursday that new claims for jobless benefits fell to their lowest weekly level in the last year, a …
US Senate confirms Walsh As A US Labor SecretaryMarty Walsh, the two-term mayor of Boston, was confirmed as the Labor secretary by the Senate in a 68-29 vote …
American Rescue Plan Act Provides Additional Sick and Family Leave Credits for Employers:On Thursday, March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into …
DOL Proposed Rule Changes under the Fair Labor Standards Act:On March 11, 2021, the U.S.Department of Labor announced a proposal to withdraw the independent contractor and Joint Employer …
CDC Released New guidelines for vaccinated people:On March 8, 2021, CDC(Centers for Disease Control and Prevention) released new guidelines for vaccinated people, guidance must balance the risk to …
The United States would have enough Covid-19 vaccine doses for every adult American by the end of May, earlier he said we would have enough vaccine for every adultAmerican …
President Joe Biden has terminated the U.S. entry ban on new immigrants implemented by the Trump administration under Presidential Proclamation 10014. This ban, whichhad been set to expire on …
Congress is working this week to finalize the third stimulus check eligibility guidelines. By the end of this week, President Joe Biden's $1.9 trillion stimulus bill should offer a clearer …
The U.S. Department of Labor is expected to announce that it will not enforce Trump administration rules.The rules, finalized in the last days of former President Donald Trump’s administration, affect …
U.S. Citizenship and Immigration Services (USCIS) recently announced that the initial registration period for the fiscal year (FY) 2022.All H-1B cap cases must be entered into the electronic registration system …
On his first day in office, President Biden issued an executive order, that will launch an all-of-government effort to provide equitable emergency economic relief to working families, communities, and small …
The Biden Administration issued a memorandum on January 20, 2021, to THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES imposing a Regulatory Freeze Pending ReviewNo regulations or rules are to be …
Organizations are struggling to hire quality talent as only 16 percent of new hires have the requisite skills for both their current role and the future, as per a new …
Dr. Anthony Fauci, White House coronavirus advisor, in a conference with President Donald Trump, disputed the President's remarks that the U.S. is "rounding off the corner" over the disturbing data …
Pfizer's CEO Albert Bourla said in a Sunday conference that its vaccine, which the pharmaceutical giant has been investing and developing to treat the COVID-19, has been set to release …
In a conference held earlier this week, Assistant Secretary for Health Adm. Brett Giroir told the reporters, "We are all concerned about the increase in cases we are currently seeing …
The largest online commercial giant, Amazon, has started the screening process for its employees, who work in the company's warehouse, for coronavirus symptoms. The company said in a notice as …
PricewaterhouseCooper (PWC) has declared promotions and monthly bonuses to its employees on October 1, 2020. According to earlier media reports, PWC had previously declared 25% pay cuts from its managerial …
The U.S Food and Drug Administration (FDA) has issued warning against hydroxychloroquine and chloroquine clarifying its interaction with the drug remdisivir, reducing the antiviral activity of the Coronavirus. This comes …
The WHO officials are currently reviewing new evidence which suggests that the possibility of air transmission of the COVID-19 viruses. WHO had earlier declared that the virus is transmitted only …
The World Health Organization has declared a warning against the Coronavirus spread as the number of cases continues to surge in the U.S. WHO Director-General Tedros Adhanom Ghebreyesus, in a …
The European Medicines Agency (EMA) has recommended 8 new medications which are yet to be approved while citing a negative opinion over an anti-tumor drug. The committee recommended conditional marketing …
According to Dr. Anne Schuchat, the principal deputy director of the Centers for Disease Control and Prevention, said, "We’re not in the situation of New Zealand or Singapore or Korea …
Tech Giant Apple declared earlier this week that it will be reclosing its 30 national stores worldwide as the coronavirus cases surge again. Up till today, Apple has closed a …
With the growing Coronavirus cases, the World Health Organization (WHO) has recommended countries to foster future plans for country-wide lockdown, along with other mandatory restrictions to curb the surging cases. In …
The officials of the U.S. Food and Drug Administration (FDA) have discussed the agency's contribution to the development of drug products that treat rare diseases. The agency claims that while …
The Volkswagen Group is reassigning responsibilities for the management of the brand and the Group. The Volkswagen core brand is to be led by the brand’s previous COO, Ralf Brandstätter …
According to a recent study conducted at the Wanzhou District of China, researchers compared the response of the antibody from 37 symptomatic patients to that of 37 asymptomatic patients. The …
The unemployment benefits in the U.S. have reached a sum total of 1.5 million, which is worse than what was expected at 1,3 million. Workers receiving benefits under all programs …
The Office of Pharmaceutical Quality (OPQ) under the U.S. Food and Drug Administration (FDA) has issued a new report that gives insights into the agency's quality of drugs and biologics …
Patrick Pichette, who worked for Googe as Cheif Financial Officer, has been appointed as the new Chairman of the Board by Twitter. Patrick Replaces Omid Kordestani, who will stay forth …
Google announced Prabhakar Raghavan as its new Head of Search earlier this week. He will be taking over Ben Gomes, who will be moving to a different role within the …
The World Health Organization (WH0) has sparked controversies after its top official, Director-General Tedros Adhanom Ghebreyesus said, "Communicating complex science in real-time about a new virus is not always easy, …
The US Food and Drug Administration (FDA) began publically listing the names of the company that has been removed from the antibody test list earlier this month. In its initial …
PepsiCo has announced Wern Yuen as the new CEO for Asia-Pacific, Australia, New Zealand, and China ("APAC"), overseeing all of PepsiCo's operations in the region. He will begin its role …
One of the largest PR Consultancy Firm, Edelman, declared earlier this March that it shall it preserve all its 6000 staffs amidst the COVID-19 pandemic. However, after three months as …
Tesla's CEO Elon Musk has tweeted tagging Amazon's CEO Jeff Bezos stating that he thinks it is time to break up. His tweet comes after writer Alex Berenson took to …
As much as 8 million Americans have received unemployment benefits amidst the COVID-19 pandemic crisis. This newly added benefit under the CARES Act covers gig workers, independent contractors, self-employed persons, …
The U.S. Food and Drug Administration (FDA) has successfully updated its clinical trial amidst the COVID-19 crisis that addresses new questions concerning the post-marketing requirements, video conferencing, and imaging centers. …
The online payment platform Paytm has asked its employees to surrender their Privilege Leaves (PL) collected leaves till 35 days and all other leaves that they have currently accumulated (Casual …
Tech Giant IBM has laid off its employees amid the COVID-19 crisis. The company has instigated a fresh round of lay-offs in at least five states across the U.S. The …
The online social media platform, Twitter, has announced permanent work from home for its employees until they feel the need to come back or when everything goes back to normal. …
The U.S. Food and Drug Administration (FDA) has updated its guidance on the clinical trials amidst the pandemic to address how and when the sponsors and application holders should report …
The online payment platform, PayPal, has reported a stark rise in the segment of online digital payment from customers aged 50 years and above, which is its highest increase in …
After new cases of COVID-19 were discovered in China, consumers have started to stock up oil and other supplies as fear for the pandemic grows globally. The country reported 82% …
The U.S. Food and Drug Administration (FDA) has issued two guidance to accelerate the COVID-19 treatment process as well as develop the drugs to prevent the spread. “Accelerating …
Tech Giant Amazon announced earlier this week to extend the hourly wages and double overtime pay for its employees in delivery jobs and warehouses till 30th May. The policy was earlier extended …
According to Melissa DeRosa, secretary to Gov. Andrew Cuomo, the New York Department of Labor has paid about a sum total of $7.4 billion to unemployment claims to around 1.7 …
As the world struggles to fight the deadly coronavirus, global funds investments in Chinese stocks of more than 800 funds reached nearly $2 trillion in assets under management. This is …
The Center for Drug Evaluation and Research (CDER) under the U.S. Food and Drug Administration (FDA) released new guidance and manuals that explain the internal process of identifying and evaluating …
The ex-Goldman and Sachs CEO, Lloyd Blankfein said in a conference earlier this week that the large companies, the ones who operate overseas, must be reluctant to take taxpayer money …
The US-funded study by the National Institutes of Health, conducted by the researchers of New York-Presbyterian Hospital and Columbia University Irving Medical Center in New York City, has found that …
The regulatory agencies in France, Switzerland, and France have issued warnings against the fraudulent use of products available online, which can be used for diagnosing, preventing infections associated with the …
Committee for Advanced Therapies (CAT) has recommended the European Medical Agency (EMA) against the usage of unapproved and unregulated cell therapies that cites potential fatal side effects. According to the …
The European Commission and the European Medical Agency (EMA) have updated their guidance on clinical trials over the COVID-19 pandemic. The guidance further adds more information about distribution, data verification, …
Earlier this week, nine industry groups formed an allegiance representing various banks and credit unions of the nation against the delays caused by the government loan portals online via the …
DBS Bank in Singapore reported that its first-quarter profit fell over 29% ( around $829.2 million) in the first quarter in January-March this year. The bank further stated that it …
The Food and Drug Administration (FDA) has relaxed certain premarket requirements concerning mental illness or psychiatric issues concerning the pandemic outbreak and with a view to support depression, obsessive-compulsive disorder, …
As rough as about 22 million people have registered themselves for the unemployment insurance following last week, as recorded after April 11. However, the fraudsters have found a way to …
The Internal Revenue Services (IRS) has been depositing $290 billion in direct cash to the accounts of the dead people. This step comes ahead within the past week as part …
The financial technology form Adyen sees a hike of 34% in the first quarter, which is estimated to be around 135.5 million Euros. CFO Ingo Uytdehaage said the company has …
The U.S. Secret Service, earlier this week, issued a public warning stating the increase in the level of email scams happening across the U.S. The USSS also stated that these …
With countries spending to limit the economic fallout starting this year, the economists around the globe have said that several countries across the globe might default on their debt in …
New York City's Mayor, Bill de Blasio, announced earlier this week that the City will be purchasing about 100,000 kits per week from a mix of local contractors and a …
According to the International Monetary Fund (IMF), the world is hit with the worst economic recession of all times. As the governments worldwide continue to suffer from COVID-19 pandemic, the …
European Markets see a lower opening rate which turned out as a result of the fading hopes over the pandemic coronavirus outbreak. Global markets continue to seesaw on hopes and …
The U.S. Food and Drug Administration (FDA) has opened a wide door of possibilities for the unapproved treatments for the Coronavirus disease (COVID-19). The treatment, though unapproved, has to be …
U.S. President Donald Trump has made several allegations against the World Health Organization (WHO) for getting every aspect of Coronavirus wrong. He further threatened to withhold the funding from the …
Elon Musk's company Tesla has announced that it will begin to slash all its employee's salaries in the wake of the coronavirus pandemic. The development in the situation came as …
The managing director of the International Monetary Fund (IMF) Kristalina Georgieva has claimed that the economic fallout due to the coronavirus pandemic is worse than the financial crisis that occurred …
Facebook CEO Mark Zuckerberg has announced a $1000 bonus to its employees to cope up with the shortages of household supplies amid coronavirus pandemic. The decision comes as a special …
According to reports, President Donald Trump is calling $2 trillion as a part of the government emergency response to Coronavirus emergency pandemic. A major can be seen from the Democrats …
Considering the increase in the coronavirus cases (COVID-19) in the U.S., the regulators such as the Medical and Healthcare product Regulatory Agency (MHRA) of the U.K. and the Food and …
After a new study that turned up the chapter of Coronavirus surviving in the air, the World Health Organization (WHO) declared that all the medical staff must consider mandatory airborne …
The White House and Senate have come to terms over a $2 trillion bill to measure up with the drastic downfall in the country's economy due to Cornavirus disease. Senate Majority …
Elon Musk's SpaceX has reported at least one positive case of coronavirus (COVID-19) in its headquarters in Hawthorne, California, which has led the company to send some of its employees …
California Governor Galvin Newson declared a statewide stay at home orders concerning coronavirus scare. While declaring the orders, Newson said, "We need to bend the curve in the state of …
The U.S. Food and Drug Administration (FDA) is doing whatever it can to speed up the access to potential COVID-19 treatments as early as possible, considering a year's time that …
Microsoft's co-founder Bill Gates has stepped down from the company's board of members to work toward charity organizations to work more on Philantrophic front concerning global health, education, and climate …
The largest retailer in the U.S.— Walmart—has shortened the working hours of its employees further as a measure to stop the spread of deadly coronavirus amongst its workers. The retail …
The World Health Organization (WHO) declared coronavirus (COVID-19), the deadly disease that has killed more than 4500 people worldwide. The organization had last declared the spread of H1N1 as pandemic …
Oracle measures an unexpected rise in its share of 5%, as the company reported fiscal third-quarter earnings and quarterly earnings guidance that was better than analysts had expected. The company’s …
The top U.S. financial firms JPMorgan Chase and Co. and Goldman Sachs have asked its New York metro employees to work from home amidst the deadly coronavirus spread. People traveling …
With a large number of people getting affected by the disease, the Trump administration has mandated sick paid leave to the private industry workers who have been affected by the …
The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it …
The former executive of Ernst and Young, Shyam Gidumal, has been named as the new Cheif Operating Officer for the coworking start-up WeWork. This is the first major C-Suite level …
The banking firm Wells Fargo has confessed its involvement in frivolous malpractices in sales, and it will be paying $3 billion settlement to the Justice Department and the Securities and …
One of the Big Four, Deloitte, has decided to stop offering its non-auditing services to all its clients in India. This comes weeks after another Big Four accounting firm — …
The U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issues warning letters to Outlook Pharmaceuticals as there was a sponsored Google link that did not include …
Medical insurers, last week, predicted that the employer medical benefit costs will continue to rise at the same rate this year in Asia-Pacific Region, as it was last year. This …
The tech giant, Microsoft, has introduced a policy to the non-employees, who work for other companies but provide services to Microsoft, that they will be given regular hourly wages even …
Even with the havoc that the deadly coronavirus has dawned on the U.S. market with 20 percent of the market crash, the private firms in the U.S. have hiked the …
The US Food and Drug Administration (FDA) has recently released a report that details its work on establishing its Accreditation Scheme for Conformity Assessment (ASCA) pilot in 2019. The reports …
Goldman Sachs, the Wallstreet Giant is competing head-to-head with the tech giants of Silicon Valley in recruiting engineers as developers for the banking and fintech industry. George Lee, who is …
Eileen Naughton, who worked for 14 years with the company, is stepping down from her position as Vice President of People Operations. According to Pichia, CEO, Google has reportedly added …
Donna Morris, Chief Human Resource Officer (CHRO) of Adobe, has called it quits to pursue another career opportunity. The current executive vice president, Gloria Chen, who is a 20-year Adobe …
The U.S. Food and Drug Administration (FDA) has finalized a set of 6 new guidance documents for the gene therapy development and other new draft guidance that interprets close relativity …
The E-Commerce Giant Amazon has warned its staff to step back from criticizing the company's policies over climate change and the expansion of its cloud computing technologies to oil and …
According to the American Express' reports on the fourth-quarter results, the company's cardless revenue shoots up to $11.365 Billion than the expected $11.36 by the analysts. The company's shares have …
Google has been perceived by 247,000 business and STEM students as the top company for creating an inclusive workplace, Universum announced. The tech giant was followed by Microsoft, and both …
The US Food and Drug Administration FDA has issued a warning to the public and an Electronics Company, General Electrics, for detecting a flaw in a health-care device that interferes …
The Tech Giant Microsoft has demonstrated the designing outlook of its application on the dual-screen laptop computers set to launch before the beginning of the holiday seasons this year. The …
The US-based e-learning platform Springboard, which is aimed at upskilling workforces from tech, has raised an estimate of $11 mn funds alone with Reach Capital, an investment company, leaving the …
The US Food and Drug Administration FDA released a notice to the public on the results that came after conducting a clinical trial for Eisai’s weight management drug Belviq (lorcaserin), …
The e-commerce giant, Amazon, recently warned its users to uninstall a Browser Extention named Honey, which is invested with around $4 Bn by PayPal, as it possesses a security risk …
The beginning of the year did not bring any good news for the giant banking firm, Wells Fargo, as it saw a drop of 50 percent in its fourth-quarter. The quarterly …
The Gurugram headquartered Walmart India has announced layoffs at its executive level, letting go of a third of its top executives. Following this week, another big firm OYO announced layoffs …
The Medical Device Coordination Group (MDCG) has launched new guidance that targets device cybersecurity norms which will help the device manufacturers fulfill various cybersecurity norms that pose a threat to …
Google recently introduced one of its latest tech innovation on Google Assitant to read long articles out loud. The tech giant said that the software designed for this purpose is …
The India-based firm, Tata Steel has extended its policy to cover all health benefits for its LGBTQ+ (Lesbian, Gay, Bisexual, Transgender, Queer, Questioning, and other allied communities) employees. The law …
The Hershey Company has announced new hiring that will take up the positions for the role of president, Chief Growth Officer, and the promoted position of CHRO. In light of …
The International Organization for Standardization (ISO) announced its revised standard to address the application of risk management to medical devices. The standard highlights the detailed benefit that one can expect …
Jamie Dimon, Chief Executive Officer (CEO) of the accounting firm J.P. Morgan Chase and Co., tackled allegations of racism cases taking place at the company's branches in the Phoenix area …
In a study conducted by a staffing firm last year, the salary for the vocational jobs has grown one high up than to engineering and MBA jobs in 2020. In …
The new Federal Law initiates modifications in the overtime rule that customizes the pay for the overtime employees. To have white-collar exemptions, the employees must be paid with at least …
The Europian Commission (EC) released eight documents on technical specifications for Unique Device Identifiers (UDIs). Amongst these, four of the documents are related to Basic UDI-DI for manufacturers to use …
Google's co-founders Larry Page and Sergey Brin have declared their step down from the management position from Alphabet, Google's parent company. While the news came in as a little surprise …
On research conducted recently, it is found that the remote employees can develop a rich bond with their colleagues even when they are working remotely. According to the research data, …
Adaptive clinical trial design for drugs and biologics has received finalized guidance by the US Food and Drug Administration (FDA). The 33 paged guidance recommends on principles of adaptive trial …
Expressing concerns over the unfair politics getting on the way of fair contesting, Amazon declared that it is contesting for a $10 Bn award by Pentagon for cloud computing to …
The World Health Organization (WHO) drafts new guidance on data integrity elaborating the elements to make the data stay safe and reliable in production and pharmaceuticals control. The guidelines also …
About 96 percent of Indian senior executives at the management level of their companies have reported that Indian workers are found to be highly engaging in their workforce when compared …
AI-based recruitment technology startup named Jobiak has raised $2.3Mn in a seed funding round instigated by a group of investors and entrepreneurs Jane Hirsh (former CEO/ Chairman of a major …
According to the market report, business intelligence in the healthcare industry has added significant advancement in analyzing the medical records and stats with the help of advanced technical aspects of …
The smallpox drug development guidance, which was released last year in July, lacked clarification on certain aspects of drug development to treat smallpox. The US Food and Drug Administration, however, …
The financial executives say that it is mandatory for financial institutes to think and behave like the tech companies. At an event in Guangzhou, China, David Rafalovsky, chief technology officer …
Freelancers willing to work in the field of data analytics and virtual assistance now have a high chance to get recruited by recognized firms as demand for these jobs gets …
After an inspection unveiled the unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operation, the US Food and Drug Administration (FDA) …
The Generic Drug User Free Program (GDUFA II) received a revised 2017 draft guidance by the US Food and Drug Administration (FDA). The major objective explained in the draft guidance …
The Office of the U.S. Food and Drug Administration (FDA) that was responsible for cancer therapy approval gets renamed as the Office of Oncologic Diseases (OOD), and it's been restructured …
The database of medical device information by the European Commission, which is also called Eudamed, will be launched in 2022. The Commission also added that after a thorough and independent …
Two Indian pharmaceutical manufacturers, Glenmark Pharmaceuticals and Torrent Pharmaceuticals, and a Bahamian drugmaker Coral Pharmaceutical receives warnings from the U.S. Food and Drug Administration. The drugmakers were sent warning letters …
The Center for Devices and Regulation Health (CDRH) of the FDA, issued the FY 2020 and the final guidance list featuring few repeats from last year and new drafts on …
The Patient Experience Data (PED) in the review documentation has been raised questions on its consistency by the researches at drugmaker Sanofi. The researchers have demanded the FDA to check …
The software qualification under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) receives new guidance from the European Commission's Medical Device Coordination Group (MDCG).The guidance addresses …
With a remark made on the executive order on Medicare, President Donald Trump addressed that the drugmakers would lower their prices once they begin importation. The speech seemed to have …
The Kowa Pharmaceuticals receives untitled letters, over a youtube testimonial video posted by a patient, on claims over satin drug Livalo. The letters were issued by the U.S. Food and …
The International Medical Device Regulators Forum (IMDRF) released a 45 paged guidance on the new best practices and general principles to facilitate the cybersecurity of medical devices. The guidance is …
The officials from the European Medicines Agency (EMA) demand a need for "an adequate statistical method to extract, analyze, and interpret" the Real World Evidence (RWE) before they can translate …
Due to drug shortages, which might occur with a possibility of no-deal Brexit, a list of 24 medicines has been published by the UK’s Medicines that cannot be parallel exported …
The U.S. Food and Drug Administration (FDA) drafted new guidance on explaining the improvement by the sponsors in the medical devices clinical investigations by including the patient's experiences, perspectives, and …
In an announcement made by the U.S. Food and Drug Administration (FDA), it declares final guidance explaining that it will delay the verification requirements for salable returned drugs. It further …
A preliminary list of the New Drug Application has been released by the U.S. Food and Drug Administration (FDA), which will be converted to the Biologics License Application (BLA) on …
The U.S. Food and Drug Administration (FDA) has drafted new guidance on the electronic submissions for medical devices with both bindings and nonbinding provisions intact. The drafted guidance is formed, …
The U.S. Food and Drug Administration unveils its new plan on modernizing the tech plans in order to match up the level of advancements in the trending data-rich applications and …
A new tool developed by the U.S. Food and Drug Administration (FDA), can now predict whether an immune response can be mounted on the body to prevent the activity of …
The Food and Drug Administration's Center for Devices and Radiological Health initiates the first step to operationalize New Safety and Performance Based Pathway and has issued performance criteria and testing …
The CEO of Novartis, Vasant Narasimhan, had told an investor conference for making new commitments to the U.S. FDA on reporting regular data integrity issues, considering its fallout from the …
Picato is an ingenol mebutate gel to treat an excessively sun exposed skin condition called keratosis. The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has begun reviewing data on …
Before its final release, the draft guidance on assessing the benefits of the medical devices on the weight loss has been circulated with a discussion paper in the audience and …
The Unified Code for Units of Measure (UCUM) now has the latest set of codes, which can be used for electronic submissions for drugs and biologics, and the U.S. Food …
The submission period for the Quality Metrics Feedback Program, which was instigated by the U.S. Food and Drug Administration (FDA) in June 2018, has been reopened with another 120 days …
The U.S. Food and Drug Administration (FDA) issued a warning letter to an Indian manufacturer, Lantech Pharmaceuticals, for detecting N-Nitrosodiethylamine (NDEA) and N-Nitrosodimethylamine (NDMA) impurities in the Valsartan Active Pharmaceutical …
The Center for Devices and Radiological Health (CDRH) of the U.S. FDA decides to seek expert advice and form an advisory panel to evaluate and review data on the norms …
The draft guidance on the prostate tissue ablation devices receives support from the industry trade associations to revise and revisit certain sections of the drafted guidance on the clinical testing …
The European Medical Agency (EMA) offered cardinal line-by-line edits and comments on an FDA's recently released draft guidance on biosimilar drugs for comparative analytical assessments. The comments and edits by …
The Center for Drug Evaluation and Research department of the FDA issues warning to the Indian based active pharmaceutical ingredient (API) manufacturer CTX Life sciences Private Ltd. and China-based drug …
With the FDA's new plan to consolidate the original reviews of medical products into an integrated review, the academics and researchers, from the most eminent institutes across the globe, have …
The FDA issued warning concerning the 3 Hepatitis drugs, namely, AbbVie’s Mavyret (glecaprevir/pibrentasvir), Merck’s Zepatier (elbasvir/grazoprevir) or Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir), which was initially thought to improve the condition of the …
The U.S. Food and Drug Authority (FDA) released a finalized guidance on the cancer trials, recommending that only Placebos should be used in case of select circumstance, taking into account, …
In a July 24th statement, the U.S urged Europe's Medical Devices and In-vitro Diagnostics Regulations to delay the new implementation by three years to “allow for US exporters to adapt …
The Government Accountable Office (GAO) has demanded the FDA to improve the rate of first cycle approvals for generic drugs considering an increase in the clarity and consistency of reviewer …
The final amendments on the drug pricing regulations were announced by the Government of Canada due to excessive prices of the patented drugs with the new regulatory tool. The demand …
The FDA recently issued finalized labeling statements, which it released two years ago, in context to the Child Resistant Packaging (CRP) for over-the-counter (OTC) and prescription drugs. Although the 16 …
The U.S. Food and Drug Administration, on its recent announcement, declared inactivating drug and manufacturing establishment listings that are not current in one month. The decision is made taking into …
The national Good Manufacturing Practice inspectorates are now to associate themselves with the international standards under the latest revised guidance on the quality system requirements. The inspectorates are also needed …
The drug price for medicare gets deductions in the increased price transparency by the US Senate Committee on Finance. With the vote of 19-9, the bill sees consideration by the …
The sponsors of metal expandable biliary stents receive an assisting set of final guidance in preparing 510(k) submission to gather premarket experience. The present guidance ousts the 1998 guidance on …
The first medicine to treat tumors with a specific mutation receives conditional approval from the European Medicines Agency’s (EMA) human medicines committee (CHMP). The medication promises to work on the …
The single-use medical devices under the Medical Device Regulation (MDR) of the European Commission (EC), receives Common Specifications (CS) for reprocessing. The Common Specification (CS) is drafted following the criteria …
The medicinal products mentioned in the Commission Delegated Regulation (EU) 2016/161, receives a thoroughly revised Question and Answers on implementing its safety features. The drafted questions and answers format revises …
According to the FDA's new drafted guidance on Gonadotropin-Releasing Hormone (GnRH) analogues can treat Advanced Prostate Cancer. The drafted guidance will help sponsors in analyzing the safety and security associated …
According to an analysis by the U.S Food and Drug Administration (FDA), the Cerebrospinal Fluid shunt valve, which is magnetic externally programmable, has a setting that can change from a …
The Food and Drug Administration (FDA) of the U.S has warned the Strides Pharma for continuously shredding the documents and violating the Good and Manufacturing Practices (cGMP) in Puducherry, India. …
The U.S. FDA issued a warning letter to Akorn for violating the cGMP at the New Jersey manufacturing facility in Somerset. The letter as discussed by the Akorn on June …
The Food and Drug Administration (FDA) declared finalization on the revised REMS Modification Guidance. The revised guidance discusses the modification and revisions to Risk Evaluation and Mitigation Strategies (REMS). It …
The essential medicines and essential in vitro diagnostics (IVD) tests, receive an updated list by the World Health Organization (WHO). The major agenda behind the updated list is for the …
The CBER of the FDA' s department, specified that due to concurrent analogies or similarities in the product of the gene therapy under the Center for Biologics Evaluation and Research, …
The Drug and Dependence section receives an all-new, 12 paged, drafted guidelines emphasizing on maintaining clarity and precision in the packaging and labeling of the drugs. It must clearly state …
With new drafted guidance on analysis, the FDA had cleared out to thoroughly scrutinize the effects and symptoms to generate the new drug for heart failure. A survey, that was …
The European Medicines Agency (EMA) and the European Commission (EC) announced on Thursday to take Germany as the member for Good Manufacturing Practices (GMP). The inspections will be conducted between …
The Medtronic receives warning from the FDA to bring modification in the Insulin Pumps. Their Insulin Pumps seemed to have been a source of the potential risk of cyber security. …
The Center for Devices and Radiological Health (CDRH) of the FDA, issued a 10-page drafted clinical recommendations to support and approve clinical test for a high-intensity ultrasound concerning prostate tissue …
The Food and Drug Administration of the U.S. issued a warning letter last month to address the quality and safety issues regarding generic drugs. An Indian, Chinese, and the U.S. …
The FDA's draft guidance on the Bioavailability (BA) is yet again in demand for changes by the drug makers and the industry groups. The guidance is 27 paged and will …
The Connecticut attorney, General William Sanders, on Monday released a more than 500-page document to fix the complaint with regards to unredacted Generic Drug prices in Connecticut. Teva Pharmaceuticals, Novartis’ …
A Guideline constituting of 7 pages has been drafted by the FDA on how to compare the new Opioids with the old ones. The guideline is believed to have elaborated …
The 37-paged guideline, which was drafted back in April 2015, has been finalized by the Food and Drug Administration (FDA) in the U.S. The guidelines focus on Promotional material submission …
QS Zürich AG, a swiss Notified Body, had called it quits to follow its designation with regards to the new EU MDR. The CEO of the former said that being …
On its third committee meeting, held earlier this month, the International Pharmaceutical Regulators Program (IPRP) welcomed Iran and Argentina as its newest members. The committee now comprises a total of …
GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) are the four new entities which will act as the “issuing entities” for the Unique …
Vida International, a Taiwan drug making firm, was issued a warning over GMP violations last month. The FDA blamed the firm for not having a regular check of the quality …
The Center for Devices and Radiological Health, which is short for CDRH, is an FDA department, which on Wednesday, released a set of 7-paged affective guidelines on the Mouse Embryos …
On a recent issue of President Donald Trump's FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee last month, the FDA …
Catalyst Pharmaceutical sued the FDA for approving a rival company's drug regulation, namely Ruzurgi, which is utilized to cure Lambert-Eaton Myasthenic Syndrome (LEMS). The biological name of the drug is …
An all-new process is drafted by the WHO that will incorporate regulators to be enlisted as WLA (WHO-Listed Authorities). WHO, in May, discussed the definitions and procedures to implement the …
With the latest transition taking place in the In Vitro Diagnostic Regulations (MDR/IVDR), the European industries are daunted by the realities and are set to go back to their contingency …
According to a new report on the survey conducted on the drug makers and manufacturers, it has come to light that almost half of the drugs that were manufactured in …
In a recent Federal case against the FDA, the Stem Cell Clinics marked the use of the Stromal Vascular Fraction (SVF) must be exempted as it regulated misbranding and adulteration …
China has reportedly been seen a fall in the initial registration of the medical devices. Statistics have recorded a drop of 25% every year and there is now no development …
NASH, short for Non-Alcoholic SteatoHepatitis (NASH), can be cured effectively with some compensated Cirrhosis, as per the new guidance that is drafted by the Center for Drug Evaluation and Research …
The European Commission, on Thursday, released an 8 eight-paged answer to the 4 set of questions that clarifies the regulatory obligations with regards to Notified Bodies. The document covers "organizational …
Dysphagia is known as difficulty in swallowing food or any liquid item. The dysfunction is caused due to geriatric syndrome and is considered to be a neurological and structural condition. …
FDA, on Thursday, drafted all-new guidance that aimed at enhancing the diversity in the clinical trials by the drug makers towards the population that rationally utilize and rely on the …
The FY 2020 report was sent to the FDA from the House, explaining and demanding the FDA, a need to foster and install certain improvements so as to effectively stimulate …
Chuck Grassley, the Chairman of the U.S. Senate Committee, on Wednesday announced that foreign countries such as China, are reportedly seen as a threat to the country's resources. He said …
In a meeting conducted last month, the FDA declared the regulation of biosimilar and interchangeable drugs with regards to Insulin. This has muddled the understanding of the working and processing …
A new development is seen in the Hospital and Healthcare industry, as FDA, on Monday, launched a new program which facilitates a more reliable and faster way to fill the …
IMDRF and the FDA have proposed to launch Artificial Intelligence to provide a helping hand in medical history. IMDRF claims that by implementing Artificial Intelligence, major medical devices can run …
The FDA, in February, released the "27-pages" of active guidelines that focus on the implementation of the continuous manufacturing in the Pharmaceutical industry. But that being said, the Drugmakers and …
The sponsors of metal expandable biliary stents receive an assisting set of final guidance in preparing 510(k) submission to gather premarket experience. The present guidance ousts the 1998 guidance on …
The sponsors of metal expandable biliary stents receive an assisting set of final guidance in preparing 510(k) submission to gather premarket experience. The present guidance ousts the 1998 guidance on …