Expedited FDA reviews examined in new study

Of the drugs approved by the FDA in 2008, those that received expedited reviews were approved more quickly, were studied in fewer patients and still have unanswered safety questions, according to new data published in JAMA Internal Medicine.“Under the Obama administration, the FDA may also change the testing requirements for many drugs prior to approval; the stated rationales are promoting innovation and reducing the time and cost of discovering new drugs,” researchers wrote. “To inform the debate about the appropriate standards for testing new drugs, we studied the development times, (Read more...)

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