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President Bush’s nomination of Andrew von Eschenbach to be the next FDA commissioner is at a stalemate as the agency and Sen. Chuck Grassley (R-Iowa) battle over access to an ongoing clinical trial investigation, an FDA source says. Read More
Sen. Chuck Grassley (R-Iowa), a frequent FDA critic, has placed a hold on Andrew von Eschenbach’s nomination to be the next commissioner of the FDA, citing the agency’s failure to respond to several requests for information about its handling of alleged clinical trial fraud.
Devicemaker Nose Breathe was cited for more than 16 violations of current good manufacturing practices (cGMPs) for its orthodontic and positioning mouthpieces in a recent FDA warning letter.
The FDA recently highlighted a number of devices approved and cleared for marketing by its Office of Device Evaluation in 2005 that "will have a particular impact on patient care."
The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at the Regulatory Affairs Professionals Society annual conference last month.
The FDA, European regulators and industry are struggling to agree on a standard for the amount of data sufficient for sponsors to submit drug applications — a key obstacle to widespread use of adaptive trial designs, sources say.
In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation.