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Federal Register notice: FDA issues a draft guidance, ANDA SubmissionsAmendments and Requests for Final Approval to Tentatively Approved ANDAs.
FDA classifies as Class 1 a Smiths Medical recall of its sterile saline and sterile water products for inhalation due to the potential exposure to inf...
FDA publishes a final guidance entitled The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended app...
Generic drugs lobbying arm Association for Accessible Medicines says new legislation introduced last week may have the unintended impact of reducing c...