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

Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls

Executive Summary

Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.

You may also be interested in...



Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises

Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.

US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

US FDA's Integrated Review Doc: Industry Says Don't Lose The Detail

Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS140937

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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