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The FDA has announced a new standard format that sponsors can use to submit data to the agency regarding human drug clinical trials — a format the agency hopes will lead to greater efficiencies in clinical research and FDA reviews of new drug applications.
The FDA plans to create an Office of Oncology Drug Products (ODP), as well as a new crosscutting oncology program, to get more cancer drugs on the market, according to an official at the agency’s Center for Drug Evaluation and Research (CDER).
The FDA will use new “complete response” letters, instead of approvable letters or not-approvable letters, to indicate that the review cycle for new and generic drugs is complete but that the applications are not ready for marketing approval, the agency said last week.
A physicians' group is calling on Congress and the federal public health establishment to create incentives that will encourage drugmakers to invest more resources into R&D of antibiotic drugs to avert a looming public health crisis.
Generic firm Barr Pharmaceuticals yesterday resubmitted an application seeking approval for an OTC version of its controversial emergency oral contraceptive, Plan B, which the FDA rejected this spring against the favorable recommendations of a scientific advisory panel.
In regulations and policy statements where the term "available therapy" is not defined, the phrase should be interpreted as therapy that is specified in the approved labeling of regulated products, with only rare exceptions, the FDA said yesterday in a guidance that aims to clarify the term.
Representatives from several U.S. law enforcement agencies said granting them 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.
Two House Republicans have joined a Senate colleague in asking for an investigation into how the FDA manages internal disagreements over the handling of drug safety matters.