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King Pharmaceuticals has blasted a recent FDA decision allowing generic firms to market versions of King’s muscle relaxant Skelaxin (metaxalone) without labeling that says taking the drug with food increases its bioavailability.
Representatives from brand and generic drugmakers joined forces last week to launch a sharp counterattack against reimportation, charging that allowing the practice could endanger Americans’ safety by greatly increasing the potential for counterfeiting prescription drugs and threatening innovation fostered by free-market competition.
A U.S. senator, alarmed by the growing momentum at the FDA toward developing an approval process for generic biologics, has urged the agency to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.
Devices and diagnostics companies need to design highly effective risk management systems to avoid becoming the next target for liability attorneys searching for the next landmark liability tort, said Kevin Quinley, senior vice president of risk services at Medmarc Insurance Group.
The FDA is threatening to disqualify a clinical investigator at the University of California, San Francisco (UCSF), from participating in further device trials for allegedly failing to report numerous patient deaths associated with recent studies of investigational devices.
Devices and diagnostics manufacturers must develop effective strategies for managing FDA site inspections to avoid common pitfalls that lead to strict regulatory enforcement actions, said compliance experts Russ Davies and Donald Segal.
In a move that could have significant impact on the bottom lines of original equipment manufacturers, the California Department of Health Services (CDHS) is endorsing the highly controversial practice of reprocessing single-use devices (SUDs).
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.