FDA Expert Panel To Review Serevent, Foradil Safety; Asthma-Related Deaths A Concern
This article was originally published in The Pink Sheet Daily
Executive Summary
Advisory committee meets on the benefits and risks of the beta-2 agonist class for the third time in three years.
You may also be interested in...
FDA Panel Suggests Adding Pediatric Risk Warning To GSK’s Serevent Label
Pediatric Advisory Committee also suggests changes in Cephalon’s Provigil label that exclude use in pediatric population.
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.
Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks
All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?