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Guidance on CVM Blood Level Bioequivalence Studies

[ Price : $8.95]

Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.

Guidance on FDA accepting Gifts on Behalf of U.S.

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Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Agios Pharma Stops Drug Development After FDA Hold

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Agios Pharmaceuticals pulls the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and with...

Janssen Biotech sBLA for Stelara in Adolescents

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Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age...

FDA Allows Pfizer to Remove Boxed Warning From Chantix

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FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric e...

Comments Sought on Third-party Review Extension

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Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Third-Party Review Under the ...

20 States Go After Generic Drug Firms for Price Fixing

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The attorneys general from 20 states file a federal lawsuit that alleges six pharmaceutical companies violated antitrust laws by c...

Feds Recover $2.5 Billion in Healthcare False Claims

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The Justice Department says healthcare False Claims Act recoveries totaled $2.5 billion in FY 2016.

FDA Expands Drug Safety Contract with Commonwealth Informatics

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FDA and Commonwealth Informatics sign a new contract to support the use of advanced drug safety review tools at CDER and CBER.

FDA Clears St Jude Medicals New Cardiac Mapping System

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FDA clears a St. Jude Medical 510(k) for its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sen...