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

Abortion Pill Mifepristone Will No Longer Require In-Person Pick Up, US FDA Concludes

Executive Summary

REMS modification implemented for the duration of the pandemic will become permanent, the agency determines in response to lawsuit. FDA adds a requirement that pharmacies dispensing the drug be certified.

You may also be interested in...



Mifepristone REMS For Pharmacies Contains Some Unusual Provisions, Continues Debate Over Access

After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.

Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination

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 Access Swings In The Balance In Post-Roe World

The US Supreme Court has overturned Roe v. Wade, but numerous avenues could help to preserve access to abortion drug mifepristone – if legislators and lawmakers are willing to walk down them.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145409

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