FDA places an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations docum...
FDA extends by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors.
FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.
FDA posts a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.
Federal Register notice: FDA makes available a final guidance entitled Drug-Drug Interaction (DDI) Assessment for Therapeutic Proteins.
Federal Register notice: FDA makes available a revised draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Developm...
Federal Register notice: FDA makes available a draft guidance entitled Migraine: Developing Drugs for Preventive Treatment.
FDA removes a two-month-long partial clinical hold on a Molecular Templates Phase 1 multiple myeloma study of MT-0169 that was based on cardiac advers...
