FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturing facility.
FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (B...
Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug...
Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Bio...
GE Healthcare has recalled its Giraffe Omnibed Carestation and Incubator Carestation due to the potential for excessive formaldehyde exposure.
A letter from dozens of patient advocacy groups urges congressional leaders to pass the Creating Hope Reauthorization Act, which would reauthorize the...
A Texas federal court rules against FDA in an ongoing Freedom of Information Act lawsuit and it must now produce EUA supporting documents in addition ...
Reuters says FDA has informed Congress about a 2023 agency inspection at Elon Musks Neuralink that found animal lab issues that warranted voluntary co...
