Improvements in safety assessment and greater mechanistic understanding of common adverse events could produce fewer safety-related market withdrawals in the future, recent comments by two leading FDA authorities suggest.
Drug Safety Forecast: Greater Understanding Could Signal Fewer Withdrawals
Efforts to foster innovation may have been the major theme for FDA in 2013, with new and expanded programs to expedite review of drugs for unmet medical needs dominating headlines, but senior agency officials also describe continued advances on the safety side of the regulatory equation.