Federal Register notice: FDA seeks comments on the draft document entitled Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data E...
Federal Register notice: FDA makes available a final guidance for industry entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Pr...
FDA releases a final guidance entitled Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products.
Federal Register notice: FDA extends the comment period associated with a 4/13 notice requesting feedback on the FDA Data and Technology Strategic Pla...
CDERs Office of Prescription Drug Promotion proposes a direct-to-consumer drug advertising survey to understand the tradeoffs made by diagnosed consum...
FDA approves Pfizers Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Strept...
The Center for U.S. Policy petitions FDA to deem a widely used clinical decision support software, Bamboo Healths NarxCare, a misbranded medical devic...
FDA posts an International Council for Harmonization final guidance entitled S12 Nonclinical Biodistribution (BD) Considerations for Gene Therapy Pro...
