FDA Shortage Notification Mandate May Not Extend To Biologics
The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
You may also be interested in...
Even as agency touts its progress and expands its powers, it acknowledges the limits of notification.
Stakeholders say it would create more confusion in the pharmacy and regulatory community; they also spar over whether volume, other criteria should be imposed to distinguish compounding types.
FDA officials state in journal article that manufacturers are not incentivized to ensure quality and base competition entirely on price.