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Federal Register notice: FDA extends the comment period on a draft guidance entitled Review and Update of Device Establishment Inspection Processes an...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...
FDA says it used new regulatory tools to approve a Novartis NDA for Piqray (alpelisib) tablets, indicated for treating postmenopausal women and men wi...