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Apothecus Combination Product CGMP Issues

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

Human Drugs

CGMP Violations Found in Torrent Inspection

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

Medical Devices

Carolina Liquid Adulterated, Misbranded Reagents

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

Federal Register

Public Meeting on Clinical Outcome Assessments

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

Animal Drugs

Animal Drug Compounding Guidance

FDA issues a draft guidance with its thinking on enforcement discretion for animal drug compounding from bulk drug substances.

FDA General

Latest FDA Warning Letters

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

Human Drugs

Cicilline, Nadler Introduce Drug Price Bill

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

Human Drugs

Act Against Female Infertility Supplements: CSPI

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

Human Drugs

BMS, Celgene Resolve FTC Antitrust Charge

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

Medical Devices

Safety and Performance-Based Device Pathway

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