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Appeals Court Remands USDA GMO Disclosure Regs

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November 7, 2025
Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg

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November 5, 2025
CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types

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October 22, 2025
FDA Moves To Crack Down on Misleading Drug Ads

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September 10, 2025
Court: FD&C Act’s Civil Money Penalty Provisions for Tobacco Products Violate Seventh Amendment

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August 6, 2025

LATEST HEADLINES

Revised Guidance on Pre-Requests for Designation Updates Process for Obtaining Agency Feedback

November 12, 2025
Jury Finds for Novo Nordisk on False Claims Allegations Linked to Off-Label Marketing, Kickbacks

November 12, 2025
New York Assembly Considers Gift Disclosure Bill

November 11, 2025
Appeals Court Remands USDA GMO Disclosure Regs

November 7, 2025
Janssen Challenges ‘Astronomical’ $1.64 Billion False Claims Judgment as Unconstitutional

November 6, 2025
Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg

November 5, 2025
Reagan-Udall Foundation Roundtable Develops Recommendations for Oncology MRCTs

November 5, 2025
Group Offers Non-UPF Certification Program

November 3, 2025
CEO Avoids Prison Time for Misbranding Conviction Linked to Devices’ Blood Lead Level Reading Errors

October 29, 2025
FDA Warns of Possible ‘Serious Complications’ Resulting From Use of RF Microneedling Devices

October 29, 2025

Latest FDA Intelligence

Industry Waits To See If FDA Makes Good on DTC Regulation Promise

November 3, 2025
FDA’s SIUU Guidance: What Now?

October 6, 2025
Questions Abound as FDA DTC Advertising Crackdown Begins

September 12, 2025
MAHA Report May Force Companies To Reexamine DTC Promotions

August 26, 2025
Continuing To Innovate During Regulatory Uncertainty

July 21, 2025

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