Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Supreme Court’s Stay Of Mifepristone Ruling Gives FDA Respite For Next Round

Executive Summary

Medication abortion pill can remain on the market under current conditions until appeal on the merits of the preliminary injunction is decided. Justice Alito dissents, noting that FDA could exercise its enforcement discretion to prevent harm to mifepristone manufacturer Danco.

You may also be interested in...



New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination

Students for Life of America requests that FDA revoke approval of mifepristone and REMS changes, claiming the agency failed to determine the medication abortion drug would not pollute waterways. The group’s fourth citizen petition follows similar claim that the agency failed to comply with the Endangered Species Act.

Supplemental Filings: CBER/CDER Real-Time Comms, DCT Fall Off, Mifepristone REMS

US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.

Califf’s Spin On FDA Staffing: Attrition Rate Too Low

Commissioner also talks drug shortages, difficulty getting key agency and industry priorities done in new pandemic legislation, and how legal challenges to FDA authority could impact pharma companies desire to develop new medicines.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148098

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel