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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes A.P. Deauville, Apothecus Pharmaceutical Corp., Carolina Liquid Che...

Cicilline, Nadler Introduce Drug Price Bill

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Reps. Cicilline and Nadler introduce legislation to strengthen FTC authority to win cases against drug companies that try to move ...

Act Against Female Infertility Supplements: CSPI

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The Center for Science in the Public Interest says FDA and the Federal Trade Commission should take enforcement action against 27 ...

BMS, Celgene Resolve FTC Antitrust Charge

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The Federal Trade Commission says that Bristol-Myers Squibb and Celgene will divest Celgenes Otezla to Amgen to resolve antitrust ...

Safety and Performance-Based Device Pathway

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CDRH technical guidance specialist Jason Ryans explains how FDA will use the new safety and performance-based 510(k) pathway.

FDA Accepts Samsung BLA for Avastin Biosimilar

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FDA accepts for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).

Safety Update on Maquet/Datascope Pumps

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An FDA device safety update says more adverse event reports have been received about intra-aortic balloon pumps by Getinges Maquet...

FDA Hits Nascent Biotech on Drug Promotion

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FDA sends Nascent Biotech an untitled letter objecting to promotional content on the companys Web site about its investigational d...

Final Smallpox Drug Development Guide Posted

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FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.

2 Fentanyl Transdermal Systems Withdrawn

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Federal Register notice: FDA withdraws ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis ...