Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European…
The FDA faulted API manufacturer Otsuka Pharmaceutical over its cleaning procedures and its maintenance of facilities and equipment. Source: Drug Industry Daily
New York’s attorney general has signed on to a whistleblower lawsuit that charges an AstraZeneca unit with Medicaid fraud. Source: Drug Industry Daily
In another attempt to quell the opioid abuse epidemic, two FDA advisory committees voted Wednesday to recommend approval of an NDA for an immediate-release opioid painkiller. Source: Drug Industry Daily
FDA commissioner nominee Scott Gottlieb was grilled by a Senate panel Wednesday over his financial ties to the industry he would be charged with regulating. Source: Drug Industry Daily
The FDA flagged API manufacturer Emcure Pharmaceuticals, citing inadequate validation, testing and reporting. Source: Drug Industry Daily
The FDA warned supplement manufacturer Sanapac for GMP violations, adulterated products and misbranding following two inspections in late 2016. Source: Drug Industry Daily
The PTO’s Patent Trial and Appeal Board ruled in favor of SteadyMed in the drug manufacturer’s challenge to a patent held by United Therapeutics over its Remodulin blood pressure drug.…
Democrats grilled industry representatives on drug pricing Tuesday at a Senate health committee hearing on reauthorizing the FDA’s user fee programs. Source: Drug Industry Daily
Drug manufacturer Gordon Laboratories received a Form 483 from the FDA for labeling problems, written procedure issues and insufficient analyses of raw materials. Source: Drug Industry Daily