FDA’s Quality Metrics Initiative Challenged on Enforceability
This article was originally published in The Gold Sheet
The pharmaceutical industry won’t let FDA force it to report quality metrics without a fight.
You may also be interested in...
Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.