Latest Posts › Pharmaceutical Industry

Share:

FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence

The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or...more

FDA Omnibus Reform Act: Examining the Policy Changes

The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more

Continuing Appropriations Act Includes FDA Reauthorization of User Fees

The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress. Key Points: ..Congress authorized FDA to...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide