FDA In Brief: FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population | FDA

FDA In Brief: FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population | FDA

FDA In Brief: FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population

The U.S. Food and Drug Administration will hold a joint meeting of the Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee on September 26 and 27. On September 26, the committees will discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. The committees will also discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana (oxymorphone) immediate-release as an example. While the agency continues to take steps to actively confront the abuse and misuse of opioids, careful attention must also be paid to the needs of patients and physicians in managing pain, particularly as it pertains to ...

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