STAT

Drug companies, patient groups urge FDA to pause commissioner’s voucher program

The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, ...

Lawmakers at the end of session try to appease both sides in drug pricing controversy

Bills address operation of federal drug discount program in Illinois ...
来自MSN

FDA 'Priority Voucher' Program Comes Under Congressional Scrutiny

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
The Baltimore Sun

FDA announces pilot program featuring real-time clinical trial monitoring

Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...
Seeking Alpha

FDA launches PreCheck program to assist in building pharma plants

The US FDA has begun accepting applications for its pilot PreCheck program, which is designed to ease the process for pharma companies to build new manufacturing facilities in the US. The program is ...
RAPS

Stakeholders offer suggestions for improving FDA’s CNPV program

During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher ...
The Boston Globe

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

WASHINGTON — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Trump’s administration is causing alarm across the agency, stoking ...