CDER issues a MAPP on policies and procedures for FDA Amendments Act safety labeling changes.
The Tufts Center for the Study of Drug Development reports that drug development targeting rare diseases is one of the fastest growing and one of the ...
FDA warns U.S. Pharmaceuticals about CGMP violations in its manufacturing of finished pharmaceuticals.
Federal Register notice: FDA withdraws approval of 11 NDAs from multiple applicants because the products are no longer marketed.
Federal Register notice: FDA withdraws approval of DHL Laboratories NDA for dextrose injection because the company has repeatedly failed to file requi...
Federal Register notice: FDA makes available an immediately in effect guidance entitled Compliance Policy for Certain Compounding of Oral Oxitriptan (...
Federal Register notice: FDA withdraws approval of 31 Apotex ANDAs after inspection concerns led to the company requesting withdrawal.
FDA issues a guidance on modifications and revisions to REMS.