FDA warns Centaur Pharmaceuticals about CGMP issues in its manufacturing of drugs at its facility in Maharashtra, India.
FDA says the deadline for submissions for the next cycle of the Advancing Real-World Evidence program is 9/30.
FDA publishes a draft guidance with recommendations for single-entity and fixed-combination antiretroviral drugs to be distributed outside of the U.S....
FDA chief scientist Namandj Bumpus says the agency is looking to revamp its advisory committees to convene panels that will solicit input on broader s...
FDA revises form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Applicati...
Three drug and medical device industry trade associations comment positively on an FDA draft guidance on decentralized clinical trials and suggest enh...
FDA approves Taiho Oncologys Lonsurf (trifluridine and tipiracil) with bevacizumab for treating certain metastatic colorectal cancer patients.
FDA converts a BD Respiratory Viral Panel from an emergency use authorization to a cleared 510(k) for detecting Covid-19, influenza A, influenza B, an...
