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 Study Registration May Help Drive FDA Acceptance

Executive Summary

US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.

You may also be interested in...



US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework

Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.

Reality Check For Real World Data: FDA’s Sentinel Network Enters “Production” Stage

FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.

340B Dispute Resolution Process On Ice As Feuds Between Pharma, Providers, HHS Heat Up

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

Topics

Related Companies

UsernamePublicRestriction

Register

LL1135495

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