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Apothecus Combination Product CGMP Issues

[ Price : $8.95]

FDA warns Apothecus Pharmaceutical about CGMP violations in the production of combination products.

CGMP Violations Found in Torrent Inspection

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FDA warns Torrent Pharma about CGMP and other violations in its production of finished pharmaceuticals.

Carolina Liquid Adulterated, Misbranded Reagents

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FDA warns Carolina Liquid Chemistries about manufacturing and distributing adulterated and misbranded reagents.

Public Meeting on Clinical Outcome Assessments

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Federal Register notice: FDA announces a 12/5 public meeting entitled 2019 Public Meeting on CDER Standard Core Sets: Clinical Out...

Animal Drug Compounding Guidance

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FDA issues a draft guidance with its thinking on enforcement discretion for animal drug compounding from bulk drug substances.

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.