Analysis of more than 800 drugs identifies recurring toxicity patterns that could inform preclinical study design and ...
In its latest Untitled Letter, the FDA took issue with a high-speed car chase that it said contradicted the motion sickness ...
Alexander is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health. Americans trust the Food and Drug Administration to make life-and-death decisions in ...
A re-analysis of FDA adverse event data from 2014 to 2024 finds that only 11.2% of the rise in serious adverse event reports ...
GSK and Cognizant aim to cut delays in drug-safety reviews, improve traceability and leave medical decisions to specialists.
The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved under the U.S. Food and Drug Administration's "Breakthrough Therapy ...
By allowing compounding pharmacies to produce certain unapproved peptides, the Department of Health and Human Services could, in the short term, put patients in harm’s way. Longer term, the policy ...
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