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Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
The National Institutes of Health has suspended production at two of its facilities following an investigation last year that found a National Cancer Institute laboratory conducting cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials, were not GMP-compliant. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More
British authorities say serious GMP deficiencies continue to plague Rusan Pharma’s Gujarat manufacturing facility, prompting them to reject all drugs from that site until it is compliant. Read More
The FDA has slapped Puerto Rico-based AIAC Pharma with a six-observation Form 483 over complaint management, cleaning records and apparent lapses in laboratory controls. Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate. Read More