US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways
Executive Summary
FY2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.
You may also be interested in...
Advanced Manufacturing Centers Of Excellence Measure Finally Clears US Congress
Nearly four years after introduction and a half-dozen legislative attempts, proposal to establish academic centers of excellence – hoped to help usher in a renaissance in US pharmaceutical manufacturing – secures passage in omnibus spending bill. New law also supports emerging technologies, building on the FDA’s Critical Path Initiative.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.