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Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Much is riding on Travere Therapeutics’ bid to gain an expansion for Filspari to treat focal segmental glomerulosclerosis ...
FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its ...
Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...
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 ...
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 ...
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 ...
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 ...
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