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In August, the FDA will release a long-awaited multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
The FDA will release in August a multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
Johnson & Johnson subsidiary Cordis has been cited by the FDA for a series of current good manufacturing practice violations stemming from a postapproval inspection at five sites that produce the Cypher drug-eluting stent.
The hesitance of drugmakers to incorporate the latest scientific and technological advances into their manufacturing operations is contributing to the high cost of drug development and the recent decline in new molecular entities (NMEs) approved by the FDA, the agency said in a new report.
Larry Pilot, a partner at the Washington, D.C.-based law firm of McKenna, Long & Aldridge, has petitioned the FDA to remove a misleading statement from Form 483s that infers the quality system regulation (QSR) requires devicemakers to identify and correct violations.
A Canadian devicemaker could start having its U.S.-bound products seized at the border unless it corrects numerous good manufacturing practices (GMP) and documentation violations discovered at its production facility.
As part of the FDA’s pharmaceutical cGMP initiative, the agency has announced it will release a multicenter analysis of internal and international current good manufacturing practices (cGMP) requirements, as well as a draft guidance on modern quality systems.
Quality system failures at a New York-based ophthalmic imaging firm have prompted a warning letter from the FDA citing 14 different good manufacturing practice violations.
The FDA has accused Colorado-based TMJ Implants of failing to report a slew of incidents in which its dental joint devices were linked to serious injuries.
Drug manufacturers that use new, advanced technologies to ensure batch quality may not have to produce multiple validation batches before the initial distribution of a new drug, according to a revised guide released by the FDA this week.