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Drug Safety Forecast: Greater Understanding Could Signal Fewer Withdrawals

 
• By Bridget Silverman

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.

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.

“Some of the major causes of drugs going off the market, I think, are largely gone” because of systematic, prospective pre-approval safety evaluation of known signals, Center for Drug Evaluation...

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