Apr 3, 2019· Comment from Association for Accessible Medicines (AAM)· FDA-2018-D-4726-0007
Comments from The Association for Accessible Medicines (AAM) on behalf of our member companies, regarding FDA-2018-D-4726: Abbreviated New Drug Application Submissions--Amendments and Requests for Final Approval to Tentatively Approved Abbreviated New Drug Applications; Draft Guidance for Industry.