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Pending industry user fee reauthorization will strongly shape the FDA’s likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
Public comments obtained from the FDA’s Division of Dockets Management are generally supportive of the agency’s draft guidance on conducting emergency clinical research when patients cannot give informed consent.
In the latest round of scrutinizing sanofi-aventis’ antibiotic Ketek, the FDA is holding a joint advisory meeting to address potential health risks associated with the drug.
The FDA has responded to complaints of ambiguity in the pedigree rule by issuing two documents outlining its enforcement priorities and further defining who is covered by the new requirement.
The use of genetic testing to develop personalized dosing for medicines can save lives and potentially billions of dollars, a group of FDA officials says.
The FDA released 26 warning letters to manufacturers selling unapproved new drugs —the second move the agency took to address the issue in a two-day period.
The FDA will hold a Dec. 11 public meeting to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory.
Wholesalers are scrambling to find a strategy to stop the FDA from implementing a drug tracking rule they say will allow a few large companies to monopolize the market, forcing smaller competitors out of business.
The long and controversial Plan B approval may by over for Barr Pharmaceuticals, but trouble for the Bush administration over its handling of the matter continues.
Perrigo is recalling 11 million bottles of 500-mg acetaminophen caplets after its metal detectors revealed small metal fragments in some of the product, which it manufactured and distributed under various store brands.