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Federal Register notice: FDA releases a final guidance entitled Physiologically Based Pharmacokinetic Analyses Format and Content...[ Price : $8.95]
Janssen files an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults.[ Price : $8.95]
Federal Register notice: FDA announces the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee.[ Price : $8.95]
Federal Register notice: FDA renews for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee.[ Price : $8.95]
Stakeholders express general support for an FDA guidance on shared system REMS and offer suggestions for changes to it.[ Price : $8.95]
Helius Medical Technologies seeks de novo clearance of the portable Neuromodulation Stimulator device for treating chronic balance...[ Price : $8.95]
Sanofi settles a Securities and Exchange Commission probe into alleged illegal payments to government officials and healthcare pro...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one medical product company Zimmer Biomet.