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

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
STAT

FDA broadens search for new top drug regulator after early setbacks

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...

Rx Inspector: ProPublica’s New Tool Provides Drug Info the FDA Won’t

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories that made them.
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Exclusive - US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and ...
STAT

FDA review of drugs is slowing while application delays are growing, analysis finds

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...
Reuters

Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

Reviews of Sanofi’s diabetes drug Tzield and Disc Medicine’s blood-disorder medicine bitopertin stalled Tzield pushed back after adverse event reports; bitopertin delayed two weeks amid efficacy and ...