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FDA Commissioner Mark McClellan last week fired off a letter urging Canadian authorities to more aggressively regulate internet pharmacies in the wake of a Minnesota study that found safety violations at several sites.
The time limitations defined in an FDA draft guidance on dispute resolution would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete, according to PhRMA.
To thwart drug counterfeiting, the FDA wants drugmakers and distributors to implement electronic tracking systems within the next three years, according to the final report of the agency's Counterfeit Drug Task Force released Feb. 18.
Adding race and ethnicity reporting requirements to FDA MedWatch forms is liable to impede companies’ postmarket adverse event reporting efforts and be of little scientific value, according to comments recently submitted to the agency.
The FDA has granted generic firm Ivax final approval to market a version of Bristol-Myers Squibb’s (BMS’) Type 2 diabetes drug Glucovance (glyburide/metformin HCl), Ivax said yesterday.
Continuing its enforcement efforts against companies that facilitate drug reimportation, the FDA issued a warning letter Wednesday to a West Virginia storefront operation it accused of violating federal law by working with a Canadian internet pharmacy to import lower-cost Rx drugs into the U.S.
Even as the FDA urges industry to move toward electronic track-and-trace technologies as part of the agency’s campaign against counterfeit drugs, drugmakers and other interested parties are still trying to figure out how to do that — and what it would cost.