Drug Safety’s “Equal Voice” To Be Considered At Internal CDER Workshop
Executive Summary
Review staff from the Center for Drug Evaluation and Research will meet in December to discuss how to implement the concept of giving an "equal voice" to safety personnel during regulatory decision-making
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Review staff from the Center for Drug Evaluation and Research will meet in December to discuss how to implement the concept of giving an "equal voice" to safety personnel during regulatory decision-making. The safety summit is a step toward "positive, cultural, real changes we are making in the review process," CDER Director Janet Woodcock said. Review staff at the level of team leader or higher are invited to the meeting (see chart: " 1 CDER Invites Safety Team Leaders To December Post-Market Forum "). As stipulated under the "Safety First" initiative, safety deputies in each CDER division will manage pre-and post-market drug safety issues, and each group will have equal voice in decision-making, according to a memorandum of agreement signed by CDER's Office of New Drugs and Office of Surveillance and Epidemiology (2 (Also see "FDA Drug Review, Surveillance Offices Agree To Share Safety Authority" - Pink Sheet, 7 Jul, 2008.), p. 10). These new posts - a deputy director for safety and a safety regulatory project manager in each review division - will be critical to CDER's efforts to track safety issues with the same focus that it has placed on application review ("The Pink Sheet," March 3, 2008, p. 4). The year before, the divisions added associate directors for safety and safety project managers, but those were not full-time, dedicated positions (3 (Also see "Postmarket Safety Managers Begin Oversight Roles In Drug Review Divisions" - Pink Sheet, 16 Jul, 2007.), p. 16). The summit, part of the effort to restructure and improve center performance as a result of provisions in the FDA Amendments Act of 2007, will "merge with the good management practices we'll be launching," Woodcock said. The CDER director made her remarks at a Sept. 26 briefing for reporters to mark the one-year anniversary of the passage of the FDA Amendments Act. The good management practices, expected to roll out "in the near future," according to the FDA, will provide a timeline to make sure the agency's reviews and sign-offs are done on deadline to give pharmaceutical companies time to correct or enhance applications if necessary (4 (Also see "FDA’s Good Review Management Practices To Debut In “Near Future”" - Pink Sheet, 16 Sep, 2008.)). - Becky Jungbauer ([email protected]) |