In With The Old? 2013 To Mark Rebirth Of CDER’s Pharmacy Compounding, Medical Imaging AdComms
FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.
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Agency terminates the panel, which has not met since October 2013, after finding it was “no longer needed.” The committee’s activities will be taken up by the anti-infective drugs panel, which has been renamed the Antimicrobial Drugs Advisory Committee.
After years of widespread vacancies on advisory committees, the Food & Drug Administration appears to have tackled most of the problems. But there are a couple of significant outliers, most significantly the Dermatology & Ophthalmic Products Advisory Committee. Will changes in conflict of interest rules and a new recruitment effort help FDA find and retain advisory committee members?
New review model’s elements, including the mid-cycle communication and late-cycle meeting, helped make for a smoother advisory committee process for Janssen’s Olysio and Bayer’s Adempas. The sponsors and FDA review staff were able to reach agreement on labeling and other review issues in advance, narrowing the scope of matters requiring vetting by the expert panels.