Follow-On Biologics, Drug Importation Get Split Decision From Bush Administration
This article was originally published in The Pink Sheet Daily
Executive Summary
Memo on potential amendments to FDA Revitalization Act threatens veto if importation provisions are attached and expresses concern about a generic biologic pathway but does not declare it unacceptable.
You may also be interested in...
PDUFA/Drug Safety Bill Moves Toward Senate Floor
Revisions to DTC and pediatric sections seem possible after ranking member Enzi supports two failed amendments.
Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.
Pink Sheet Podcast: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC
Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access, the SCOTUS reaction to the fight against misinformation, and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews.