Federal Register notice: FDA makes available a draft guidance entitled Considerations for Rescinding Breakthrough Therapy Designation.
Federal Register notice: FDA makes available a draft guidance entitled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contami...
Federal Register notice: FDA makes available a final guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology ...
FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.
AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.
Federal Register notice: FDA seeks comments on an information collection extension entitled 510(k) Third-Party Review Program (OMB Control Number 0910...
Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Device Listing for Manufacturers...
New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...