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Federal Register Notice: FDA releases a draft guidance, Initial Completeness Assessments for Type II API DMFs Under GDUFA.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, Acute Bacterial Otitis Media: Developing Drugs for Treatment.[ Price : $8.95]
Takeda Pharmaceuticals and Lundbeck submit an NDA to FDA seeking approval for vortioxetine for treating major depressive disorder ...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Andes Natural Skin Care, Arkadiy Kisin/White Forest Solutions, Canadadrugs, EMG ...[ Price : $8.95]
FDAs Seattle District Office warns Oregon Aesthetic Technologies about Quality System and other violations in its manufacturing of...[ Price : $8.95]
The Corporate Whistle Blower Center calls on people with knowledge of drug or medical device company illegal activity to come forw...[ Price : $8.95]
FDA sends Zimmer a Warning Letter over manufacturing and validation issues cited after an inspection at a manufacturing facility i...[ Price : $8.95]
FDA asks a DC federal court to dismiss a whistleblower retaliation suit brought by six CDRH employees.