The landmark litigation attempting to remove mifepristone from the market involves issues central to the US Food and Drug Administration’s regulation of drug products. The outcome will impact who is able to file suit to seek reversal of a drug approval and whether courts can set aside the agency’s evaluation of scientific data.
Breaking Down The Arguments In The Mifepristone Case
Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.
More from US FDA
• By
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
• By
Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
• By
Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
• By
The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
More from Agency Leadership
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.