Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

US FDA Gives Sponsors Some Leeway In Studying Drug Effects On Driving

Executive Summary

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.

You may also be interested in...



Drug Effects On Driving Need Tiered Evaluation, FDA Says; Patient Reports Inadequate

Draft guidance describes various analyses and studies that can determine a drug’s effect on driving but doesn’t offer much advice on how to determine when a drug needs to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.

Insomnia Drug Development Programs Must Include Driving Studies, FDA Says

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.

Health Care Providers Have Knowledge Gap On Biosimilars, Accelerated Approval

FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.

Topics

Related Companies

UsernamePublicRestriction

Register

PS121957

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel