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The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The FDA is concerned that patients will have trouble complying with instructions for Purdue Pharma’s oxycodone drug Avridi, as two advisory panels prepare to discuss the effect of food intake on the abuse-deterrent opioid. Read More
NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More
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