Neurology Advisor

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.
wjla

AI Set to Revolutionize Drug Approvals

WASHINGTON (7News) — Artificial intelligence is poised to dramatically reshape the process of developing and approving new medicines, according to industry experts. Traditionally, the path from drug ...
Washington Examiner

FDA commissioner predicts ‘record’ drug approvals this year

Food and Drug Administration Commissioner Marty Makary said approving drugs for human consumption is moving at a “record” pace. Makary confirmed that the FDA’s review process will not slow down ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
RAPS

GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering ...
Scientific American

Why the FDA rejected a ‘breakthrough’ melanoma drug

The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other ...