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Eli Lilly Urges Supreme Court To Examine Constitutionality of False Claims Act’s Whistleblower Provisions

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April 1, 2026
In Releasing Draft Guidance, FDA Seeks To Improve Form 483 Responses Following Drug cGMP Inspections

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March 11, 2026
Regulatory Executive To Plead Guilty to Hiding Adverse Events, Including Patient Deaths, From FDA

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March 11, 2026
OIG Offers Anti-Kickback Guidelines for Direct-to-Consumer Drug Sales Through Programs Like TrumpRx

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February 18, 2026
FDA Will Allow ‘No Artificial Colors’ Labels for Products Not Using Oil-Based Dyes

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February 13, 2026

LATEST HEADLINES

Eli Lilly Urges Supreme Court To Examine Constitutionality of False Claims Act’s Whistleblower Provisions

April 1, 2026
Final Guidance Describes Roles of Patient Preference Information in Submissions, FDA Decision-Making

April 1, 2026
DTC TV Ad, Podcast Misrepresent Indications for Bladder Cancer Drug, OPDP Alleges in Warning Letter

April 1, 2026
FDA Seeks Input on Digital Health Technologies for Use in Clinical Trials for Drugs, Biologics

March 31, 2026
Maryland Legislation Would Impose Registration, Disclosure Mandates for Disease Awareness Campaigns

March 26, 2026
AI-Enhanced Medical Technology Specifically Indicated for Pediatric Use Remains Scarce, Researchers Find

March 25, 2026
Supreme Court Won’t Hear Appeal of Medtech Exec Convicted for COVID-19, Allergy Testing Schemes

March 25, 2026
DOJ Develops First-Ever Uniform Corporate Criminal Enforcement Policy, Urges Self-Disclosure

March 19, 2026
Guidance on Weight Loss Devices Specifies Risk-Benefit Factors Considered by FDA Reviewers

March 18, 2026
CBER Sends Untitled Letter Over Adverse Event Reporting

March 13, 2026

Latest FDA Intelligence

The AI Revolution: Regulatory and Legal Considerations for the Use of Artificial Intelligence Tools in Advertising and Promotion

March 19, 2026
Senate HELP Committee Chair Details FDA ‘Bottlenecks’ Hindering Patient Access to Innovative Devices

February 19, 2026
OPDP Keeping a Close Watch on Companies Cited in September Enforcement Blitz

February 1, 2026
What Now? Steps To Take on Launch Materials Intended for an Accelerated Approval After Receiving an FDA Complete Response Letter

December 3, 2025
Recent Untitled Letter Provides Insight on FDA’s View of Safety Info in DTC Ads

November 28, 2025

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