Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says
If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.
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Abbvie, Amgen, Novartis and Novo Nordisk have drugs on the list but haven’t sued yet. While they could add to the ranks of legal opposition, the Court Battle for the IRA is more about philosophy than numbers.
Pink Sheet Podcast: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer Combos
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.
Advertising Untitled Letter For Exeltis Slynd Social Media Spot Renews Attention To Online Risk Disclosure
Oral contraceptive’s ad did not contain any risk information and was not submitted to US FDA beforehand, so the letter seems an easy call. But with two citations released in as many weeks, is the agency signaling an uptick in enforcement?