EATG » Letter to FDA regarding application for Descovy as PrEP

Letter to FDA regarding application for Descovy as PrEP

April 16, 2019 – Treatment Action Group (TAG) and PrEP4All sent a letter to Dr. Debra Birnkrant of the US Food and Drug Administration (FDA), outlining and expressing their serious concerns about Gilead’s supplemental New Drug Application for Descovy (FTC/TAF) as HIV-1 preexposure prophylaxis (PrEP). There are several specific recommendations in the letter for this approval process, including recommending that the FDA convene a public meeting of the Antiviral Drug Advisory Committee.

VIEW/DOWNLOAD THE LETTER


 

Source:
Treatment Action Group
News categories: EMA/FDA, PrEP, Advocacy