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FDA enforcement of drug companies’ use of off-label promotion is being made more difficult by Amarin’s successful lawsuit against the agency and by a government website, ClinicalTrials.gov, a law professor says. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
Pfizer’s Dalian, Liaoning, China, facility received a six-observation Form 483 for retesting failed samples, poor record controls and using an open pit for a urinal. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More
The FDA cited Novartis’ Vaccines and Diagnostics facility located in Liverpool, UK, for numerous lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
Members of the House Energy & Commerce Committee requested the FDA to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More