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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...

Trump Stalls Action on e-Cigarettes/Vaping

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President Donald Trump pulls back administration plans to issue new rules on e-cigarettes/vaping to curb youth access, reportedly ...

25th Approved Biosimilar Goes to Pfizers Abrilada

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FDA hits a milestone with the approval of Pfizers Abrilada (adalimumab - afzb), a biosimilar to AbbVies Humira, which is the 25th ...

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...