CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic products.
Federal Register notice: FDA announces a 4/28 Oncologic Drugs Advisory Committee meeting to review an AstraZeneca supplemental NDA for Lynparza (olapa...
The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.
FDA releases the form FDA-483 with eight observations from an inspection at the Madhya, Pradesh, India-based Cipla facility that manufactures sterile ...
A Reuters investigative report relying on anonymous sources says FDA has rejected an application from Elon Musks Neuralink to open human trials of its...
A Senate bipartisan bill aims to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs.
FDA commissioner Robert Califf, CBER director Peter Marks, and Childrens Hospital of Philadelphia vaccine expert Paul Offit debate in the New England ...
Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...
