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 ...
Hosted on MSN

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 ...
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 ...
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 ...
MPR

FDA Cites Trial Concerns in Rejection of Tabelecleucel for EBV+ PTLD

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
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 ...