Drug Effects On Driving Need Tiered Evaluation, FDA Says; Patient Reports Inadequate
This article was originally published in The Pink Sheet Daily
Draft guidance describes various analyses and studies that can determine a drug’s effect on driving but doesn’t offer much advice on how to determine when a drug needs to progress to a higher level of scrutiny.
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Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.
Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.