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 ...
Becker's Hospital Review

FDA questions accelerated approval for RRP therapy

The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...
JD Supra

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...
MobiHealthNews

Three key questions for FDA mHealth regulation

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...
STAT

5 burning questions on the FDA’s new Covid-19 vaccine framework

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. Helen Branswell covers issues ...