BIO’s "Big Ideas" For FDA Reform Are Too Big For PDUFA
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The Institute of Medicine urges the agency to create a publicly available document setting forth benefits and risks of drugs, with periodic updates, but FDA says it has no extra resources to handle such an effort.
House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.
Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.