Drug Shortage Scrutiny: GAO Plans Study Of FDA’s Expedited Applications
Government watchdog wants to look at how the agency expedites applications that could help alleviate a shortage, but cautions that process alone cannot reduce shortages.
You may also be interested in...
GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.
House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.