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The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility. Read More
The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product. Read More
The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University. Read More
The U.S. Court of Appeals for the Federal Circuit found that a district court was overly broad in its interpretation of patents in a lawsuit by a Teva subsidiary accusing Apotex of infringing its patents for the coating on a muscle relaxant pill. Read More
The Department of Health and Human Services’ Office of Inspector General sent a letter to PhRMA seeking help in contributing to drug co-payments after a nonprofit ended its financial grants to cover patient co-pays. Read More