2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)
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Guidance Documents for Rare Disease Drug Development
Guidance Documents for Rare Disease Drug DevelopmentFDA Launches Crackdown on Deceptive Drug Advertising
The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements.ZoomMax may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use ZoomMax, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.FDA In Brief: FDA provides guidance on improving the agency’s interactions with product developers to make the drug development process more informed and efficient
FDA announces two new guidances to support enhanced communication with drug developers, help make the development process more informed and efficientReal-World Evidence
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse