Expedited Drug Reviews Raise Safety Concerns, Industry Experts Warn

Because fewer patients are studied as part of the expedited drug approval process, many such drugs hit the market with significant safety questions unanswered, a study released Oct. 28 says. Drugs approved in 2008 under the FDA’s expedited drug approval program took on average five years of clinical development time to gain approval, compared with seven and a half years for drugs under standard review, according to the study, published in JAMA Internal Medicine.
Washington Drug Letter