Five stakeholders suggest changes to an FDA draft guidance on natural history studies on rare disease drug development.
FDA warns AMMD Labs about CGMP and other violations in its production and marketing of finished pharmaceuticals.
Pharm D Solutions recalls all sterile compounded drug products due to FDA inspection concerns that practices at the pharmacy have the potential to pos...
FDA places a clinical hold on Newron Pharmaceuticals proposed Phase 2-3 pivotal studies with evenamide for treating schizophrenia due to agency concer...
Federal Register notice: FDA extends the comment period on a draft guidance entitled Review and Update of Device Establishment Inspection Processes an...
FDA Review posts the Federal Register notices for the week ending 5/24/2019.
FDA Review posts product approval summaries for the week ending 5/27/2019.
Allergan files a citizen petition asking FDA to refuse to receive and approve any ANDA that references the companys NDA for Viberzi (eluxadoline) tabl...