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.
FDA accepts for review six Merck supplemental BLAs to update the dosing frequency for Keytruda (pembrolizumab).
FDA releases the FDA-483 with four observations from an inspection at Indias Indoco Remedies.
FDA warns Akorn about CGMP violations at its Somerset, NJ, drug manufacturing facility, as well as similar violations at other facilities.