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IVD Emergency Use OK'd for Respiratory Syndrome

[ Price : $8.95]

Federal Register notice: FDA announces its Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle...

Guidance on CMC Submissions to CVM

[ Price : $8.95]

Federal Register notice: FDA releases a guidance on Two-Phased Chemistry, Manufacturing, and Controls Technical Sections.

ICH Guide on Vet Med Technical Requirements

[ Price : $8.95]

Federal Register notice: FDA posts a guidance on International Cooperation on Harmonization of Technical Requirements for Registra...

FDA Clears Bovie Medical New J-Plasma Configurations

[ Price : $8.95]

FDA clears a Bovie Medical 510(k) for six new hand piece configurations that expand its J-Plasma pistol grip surgical device.

Lipocine NDA for Testosterone Replacement Therapy

[ Price : $8.95]

Lipocine files a 505(b)(2) NDA for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult...

CVM Guidance on Two-phased CMC Submissions

[ Price : $8.95]

CVM issues a guidance on Two-Phased Chemistry, Manufacturing, and Controls (CMC) that provides recommendations on submitting such ...

Duchesnay Corrects Kardashian Drug Promotion

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Duchesnay says it has taken corrective action to address an 8/7 Warning Letter from CDERs Office of Prescription Drug Promotion th...

Amarin, FDA Enter Settlement Talks on First Amendment Issue

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Amarin and FDA agree to discuss a settlement after the company earlier this month was granted preliminary relief in its First Amen...

FDA Priority Review for Intercepts Obeticholic Acid

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FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid for treating primary biliary cirrhosis.

Sunshine Heart Trial Protocol Amended for C-Pulse System

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FDA approves a Sunshine Heart protocol amendment to modify the stopping rule criteria for the company's COUNTER HF pivotal study f...