CDRH Problematic Regulatory Paths Review On Near-Term Agenda – Feigal
This article was originally published in The Gray Sheet
Executive Summary
The Center for Devices & Radiological Health already is moving to implement agency-wide initiatives that seek to provide guidance for manufacturers of novel products, according to FDA officials
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Novel Drug/Biologics Delivery Systems FDA Workshop Slated For July 8
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Novel Drug/Biologics Delivery Systems FDA Workshop Slated For July 8
FDA is soliciting feedback on regulatory challenges posed by novel drug and biologics delivery systems - and steps the agency can take to ease their regulatory pathway
FDA drug delivery workshop
Event is slated for later this summer, "with the idea that we know that when there's a guidance written...you've got almost twice the chance of getting the first cycle of approval...than you do with no guidance written," CDRH Director David Feigal remarks at AdvaMed annual meeting March 22 in Aventura, Fla. The workshop is part of a agency-wide initiative to improve problematic regulatory paths (1"The Gray Sheet" March 24, 2003, p. 11)...