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

PDUFA's 'Real-World' Journey Expected To Be Slow Walk

Executive Summary

Manufacturers are enthusiastic about the possibility of using real-world evidence to expand product indications. But even with new resource support, they know it's a long road to get there.

You may also be interested in...



Woodcock's Legacy: CDER Organizational Improvements

In interview with the Pink Sheet, Center for Drug Evaluation and Research director discusses her 30-year career, retirement speculation, and upcoming projects.

2020 Vision For FDA's Sentinel: 'Systemic' Integration Of Surveillance Looms

PDUFA reauthorization agreement sets up fiscal 2020 as milestone for weaving active surveillance into drug review – and for keeping sponsors informed of activities that affect their products.

Diabetes Drug Safety Might Be Best Assessed With Real-World Data

Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.

Related Content

Topics

UsernamePublicRestriction

Register

PS118826

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