US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways
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...
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.
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.
CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.