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Numerous officials are defending the FDA’s Office of Chief Counsel (OCC), insisting that the agency is empowered by federal law to intervene on behalf of drugmakers in consumer lawsuits and asking that the office not be penalized for doing so.
Granting law enforcement agencies the authority to destroy drugs illegally shipped into the U.S. at the point of import would go a long way toward lightening the load of policing illicit internet drug purchases, representatives from several U.S. law enforcement agencies said.
A rule proposed last week would dramatically affect the amount Medicare pays for prescription drugs, in some cases lowering the cost to the government by as much as 89 percent.
An interagency task force established in January is developing a set of enforcement procedures that will provide various agencies with uniform and effective strategies to halt illicit drug importation.
The FDA, citing past lapses in the rules governing drug testing samples, has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications.
Three final guidances have been released that will help firms prepare and submit applications for medical imaging drugs and biological products -- agents that are used solely to diagnose and monitor diseases or conditions rather than to treat them.