Federal Register notice: FDA withdraws approval of ANDA #061579 for nonsterile neomycin sulfate powder for prescription compounding due to safety conc...
FDA releases its latest batch of Warning Letters that include Hangzhou Zhongbo Industrial Co., Longbow First Aid Products and Lymol Medical.
FDA classifies as Class 1 an Edwards Lifesciences recall of its Swan-Ganz Thermodilution Catheters manufactured between 12/26/2017 and 4/19/2018 due t...
FDA issues an Alkermes a complete response letter on its NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder.
Federal Register notice: FDA releases a draft International Council for Harmonization guidance, S11 Nonclinical Safety Testing in Support of Developme...
FDA says it is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with Abiomeds Im...
Federal Register notice: FDA posts a guidance on Immunogenicity Testing of Therapeutic Protein Products Developing and Validating Assays for Anti-Dru...
Federal Register notice: FDA issues a draft guidance, ANDA SubmissionsAmendments and Requests for Final Approval to Tentatively Approved ANDAs.