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Final Guide on Pharmacokinetic Analyses

[ Price : $8.95]

Federal Register notice: FDA releases a final guidance entitled Physiologically Based Pharmacokinetic Analyses Format and Content...

Janssen NDA for Treatment-resistant Depression

[ Price : $8.95]

Janssen files an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults.

Cardio/Renal Panel Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee.

Endocrinologic/Metabolic Drugs Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee.

Shared System REMS Comments

[ Price : $8.95]

Stakeholders express general support for an FDA guidance on shared system REMS and offer suggestions for changes to it.

Helius Neuromodulation Stimulator De Novo Submission

[ Price : $8.95]

Helius Medical Technologies seeks de novo clearance of the portable Neuromodulation Stimulator device for treating chronic balance...

Sanofi Settles SEC Case for $20.2 Million

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Sanofi settles a Securities and Exchange Commission probe into alleged illegal payments to government officials and healthcare pro...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Zimmer Biomet.

Changes Sought in Biologics Meeting Draft Guidance

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Pfizer and Lilly seek changes to an FDA guidance on formal meetings between FDA and sponsors or applicants of Biosimilar User Fee ...

Merck sBLA for Keytruda for Rare Skin Cancer

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FDA accepts for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatri...