STAT

FDA voucher program has become vehicle for political interference in drug review decisions, staffers say

Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority ...

Exclusive: US FDA taps Merck drugs with blockbuster sales potential for national priority vouchers

The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with ...
TipRanks on MSN

FDA voucher program allowing White House to intervene, STAT reports

A new FDA fast-track drug review program is increasingly allowing the White House and senior agency officials to influence which medicines are ...

US FDA approves first drug under new fast-track review program

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...
BioPharma Dive

FDA approves first drug in National Priority Voucher program

The agency gave the green light to a U.S. company manufacturing Augmentin XR, an antibiotic first approved more than two ...
BioSpace

FDA Mulls National Priority Vouchers for Two Potential Merck Blockbusters: Report

The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news.
Becker's Hospital Review

FDA taps J&J drug for priority voucher program

The FDA taps J&J drug teclistamab for its National Priority Voucher pilot, enabling expedited review for multiple myeloma treatment.
Becker's Hospital Review

FDA grants 1st approval under priority voucher program

FDA grants 1st approval under priority voucher program to Augmentin XR, expediting review and supporting U.S. antibiotic supply chain resilience.
STAT

Pharmalittle: We’re reading about the FDA voucher program, reclassifying marijuana, and more

An FDA program to fast-track drug reviews has become a way for the White House to influence which medicines make their way fastest to patients ...
MedTech Dive

FDA pilots allowing digital health devices access to CMS payment program

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect ...
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...