Latest From Bowman Cox
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.
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.
Initial product approvals will kick off a process that an FY23 spending bill provision establishes for the pharmaceutical industry to build on prior knowledge from manufacturing platform technologies. But the FDA can only designate platforms that really will expedite the development and review of new drugs and biologics.
A suite of pharmaceutical inspection measures stripped from the user fee renewal legislation were added to the US FY 2023 spending law, including provisions for new inspection priorities, remote alternatives, mutual reliance, internal FDA coordination and unannounced foreign inspections.
FY 2023 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.