FDA REFORM BILL PASSED NOV. 9 EXCLUDES 510(k)s WITH CLINICAL DATA FROM THIRD-PARTY REVIEW; SENATE SUNSET LANGUAGE PLACES IMPLEMENTATION BURDEN ON AGENCY
This article was originally published in The Gray Sheet
Executive Summary
Premarket notification submissions containing clinical data are excluded from the third-party review program in the FDA reform/Prescription Drug User Fee Act reauthorization (S 830) conference bill passed by voice vote by the House and Senate Nov. 9. The exclusion was not in either of the bills passed by the House or the Senate.
You may also be interested in...
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.
ImmunityBio Will Aim Anktiva At Large Share Of Bladder Cancer Market
Execs Richard Adcock and Patrick Soon-Shiong told Scrip the company sees an addressable US population of about 20,000 and is aiming for ease of physician adoption.
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.