News: Smallpox drug development gets finalized guidance by the FDA
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, finalized revised guidance, clearing all the aspects concerning the development of the drug.
While smallpox is believed to have eradicated in the 1980s, it is still considered as a major significant source of malfeasance by the FDA and other health officials, as it possesses life-threatening traits and could be used as a biological weapon or in terrorist attacks. Meanwhile, the revised changes in the draft guidance focus on “recommended immunological characterizations of animals in key studies.”