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Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination

 
• By Brenda Sandburg

The American College of Obstetricians and Gynecologists and 48 other groups request the FDA ask Danco Laboratories to file a supplemental NDA for an expanded indication and eliminate requirements for provider and pharmacist certification. For now, Danco is focused on updating the REMS as modified in December.

Mifepristone
Groups advocate for expansion of the mifepristone indication and elimination of its REMS. • Source: Shutterstock

As the Biden administration has fallen short on pledges to increase access to medication abortion, medical organizations are advocating for the US Food and Drug Administration to eliminate restrictions on use of Mifeprex (mifepristone) and expand its indication.

The American College of Obstetricians and Gynecologists submitted a citizen petition to the FDA on behalf of itself and...

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Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 
• By Bridget Silverman

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

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Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.