The FDA and the Agency for Healthcare Research & Quality (AHRQ) will launch an effort to advance scientific research and foster research partnerships on drug effectiveness and safety. Beginning in mid-January, Anne Trontell, M.D., FDA's deputy director of the Office of Drug Safety (ODS), will embark on a 12-month FDA-sponsored detail as a senior adviser in pharmaceutical outcomes research in AHRQ's Center for Outcomes and Effectiveness. She will promote collaborative drug safety and effectiveness research by the FDA, AHRQ, CMS, and academic and professional organizations. Her duties will include participation in effectiveness and risk communication research and outreach conduction by the new AHRQ Effective Health Care Program authorized under the Medicare Modernization Act.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.