HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Sets Outcomes Benchmarks For Actual Use Trials

This article was originally published in The Tan Sheet

Executive Summary

FDA is providing OTC switch application sponsors with pre-defined benchmarks for actual use trials, Center for Drug Evaluation and Research executive Andrea Leonard-Segal says

You may also be interested in...



FDA Panel To Influenza Home MedKit Sponsors: Get Real

Roche begins label comprehension studies this month to support development of aTamiflu home MedKit for the treatment or prophylaxis of pandemic influenza virus, under an initiative driven by the Department of Health and Human Services

Overhaul Of NDAC Process Needed For Better Switch Chances – Brass

FDA should "anchor" advisory committees' evaluations of switch applications by identifying adequate outcomes of behavioral science studies that sponsors submit, according to pharmacology expert Eric Brass

Advisory Panel Meeting Menu Includes Self-Selection Risk/Benefit Evaluation

FDA's Nonprescription Drugs Advisory Committee will tackle issues such as weighing the risks of self-selection failures against the benefit of successes when the panel convenes Sept. 25 to discuss OTC drug consumer behavior trials

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS137112

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