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 ...
MedPage Today on MSN

Study questions benefit of FDA-cleared device for ADHD

The agency is currently reviewing the study findings ...
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 ...
Daily Herald

FDA questions common practice of getting covid, flu vaccines together

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...
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 ...
Cleveland.com

FDA’s new approach raises questions about fall COVID vaccine availability

WASHINGTON (AP) — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions ...
JD Supra

FDA’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
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 ...
UUHC Health Feed

Common Questions About the FDA-Approved Alzheimer’s Blood Test

Alzheimer’s disease is a devastating condition that affects more than 7 million Americans, according to the Alzheimer’s Association. As the Baby Boomer generation ages, this number is estimated to ...