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

A Case For Driverless Cars? FDA Draft Guidance Casts Broad Net For Driving Impairment Studies

This article was originally published in RPM Report

Executive Summary

The folks at Google might find some new investors to support their driverless car project once biopharma sponsors digest a new FDA guidance that outlines an approach to evaluating psychoactive drugs for their potential to affect driving.

You may also be interested in...



Structured Risk-Benefit Framework Strikes Back: FDA Suvorexant Reviewer Cites Need for Real World Predictions

A predictable risk-benefit framework for FDA drug approval decisions has been a long-term objective of many drug developers. A big step in that direction was adopted as part of the PDUFA V agreement last July. However, FDA's briefing documents for a review of a Merck insomnia therapy suggest that step may not be heading in quite the way that industry hoped.

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.

More Like Untouchable? US Medicare ‘Protected Classes’ Stay Protected – Again

A decision made more than 15 years ago by CMS to require drug insurance plans to cover all drugs for six specific diseases has proven impervious to change. But will the protected classes remain if Part D is reformed more broadly?

Topics

Related Companies

UsernamePublicRestriction

Register

PS079803

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