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Info Collection on IND Requirements

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Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Application Re...

Health Misinformation Hurts Life Expectancy: Califf

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FDA commissioner Robert Califf says FDA and other agencies need new authorities to better combat the health misinformation that he...

New FDA Cybersecurity Safeguard Requirements

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Two Sheppard Mullin attorneys explain the provisions and impact of new FDA medical device cybersecurity requirements.

Companies Not Ready for New Cyber Safeguards: Article

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An SC Media online post says many medical device companies arent ready for new FDA cybersecurity safeguards.

FDA Sets Device Radiation Sterilization File Pilot

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FDA announces a new voluntary Radiation Sterilization Master File Pilot Program for medical devices that is open to nine companies...

Regulatory Reforms Needed for AI Devices: Shuren

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CDRH director Jeff Shuren tells an American Enterprise Institute panel that new regulatory reforms from Congress will be needed fo...

Mifeprex Judge Damns FDA for Worse Abortion Outcomes

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FDA Webview editor Jim Dickinson analyzes Texas federal judge Matthew Kacsmaryks memorandum opinion and order banning chemical abo...

What of FDAs Gold Standard After Kacsmaryk?

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A Texas judges late Friday (3/7) decision staying FDAs approval of mifepristone (Mifeprex) sees many reactions that worry about FD...

Pfizers RSV Vaccine Moves to Panel Meeting

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Federal Register notice: FDA announces a 5/18 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfi...

Panel to Mull Leqembi Confirmatory Study

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Federal Register notice: FDA announces a 6/9 Peripheral and Central Nervous System Drugs Advisory Committee to review an Eisai con...