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

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...
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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 ...
JD Supra

FDA Cosmetic Updates: New Q&As for MoCRA Facility Registration, Product Listing; Delayed Timelines for GMPs and More

FDA continues to construct its regulatory program for cosmetic products, albeit at a slower pace than the congressional timelines provided in the Modernization of Cosmetics Regulation Act of 2022 ...
FierceBiotech

Geron faces uphill battle at FDA meeting as agency questions benefit-risk profile of imetelstat

With 99% of patients experiencing an adverse event, the FDA is skeptical that the risks associated with Geron’s myelodysplastic syndromes (MDS) medicine imetelstat outweigh the potential benefit of ...
JD Supra

Navigating the FDA’s SIUU Guidance: Key Insights for Pharma and MedTech

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...