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...
Teva Pharmaceuticals recalls 13 lots of various strengths of fentanyl buccal tablets due to safety updates that were omitted in the product inserts.
