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Court Enters Consent Decree Against Philips Respironics Following Recall of Sleep Therapy Devices

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April 10, 2024

Former Device Execs Ask Supreme Court To Review Their Convictions for Alleged Off-Label Marketing

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FDA Asks for Expanded Enforcement Authorities for Remote Assessments, Destruction of Imports

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March 28, 2024

FSIS Issues ‘Product of USA’ Label Claim Rule

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March 14, 2024

Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities

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March 6, 2024

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FDA Enforcement Manual

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Guide to Good Clinical Practice

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FDA Advertising and Promotion Manual

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Guide to Medical Device Regulation

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Guide to U.S. Food Labeling Law

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FDA Enforcement Letter Database Quicksearch

The FDA Enforcement Letter Database is Thompson FDA's upgraded database of FDA Warning Letters, Untitled Letters and Cyber Letters. Type in a search term here to quickly find what you're looking for, or select advanced search to dive deeper.

Clinlaw State Database Quicksearch

Thompson FDA’s Clinlaw State Database provides comprehensive information about statutes and regulations governing clinical research for all 50 U.S. states plus the District of Columbia. The database offers brief summaries, with citations to relevant law and court opinions. Select your search terms from the drop-down menus below to get started.

FDA Intelligence

PMCPA Ruling Reinforces FDA Policy Regarding Media Interviews

April 20, 2024
Roles of Sales Reps and MSLs Are Evolving with More Electronic Promotional…

March 19, 2024
Untitled Letter Reflects Standards Set in New Major Statement Regulation

January 24, 2024
OPDP Stresses ‘Public Health’ Concerns in Enforcement Letters

January 22, 2024

Welcome to Your Compliance Expert

Top News

Court Enters Consent Decree Against Philips Respironics Following Recall of Sleep Therapy Devices

Former Device Execs Ask Supreme Court To Review Their Convictions for Alleged Off-Label Marketing

FDA Asks for Expanded Enforcement Authorities for Remote Assessments, Destruction of Imports

FSIS Issues ‘Product of USA’ Label Claim Rule

Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities

COMPLIANCE LIBRARY

FDA Enforcement Manual

Guide to Good Clinical Practice

FDA Advertising and Promotion Manual

Guide to Medical Device Regulation

Guide to U.S. Food Labeling Law

MY RESEARCH

FDA GUIDANCE

FDA Enforcement Letter Database Quicksearch

Clinlaw State Database Quicksearch

FDA Intelligence

PMCPA Ruling Reinforces FDA Policy Regarding Media Interviews

Roles of Sales Reps and MSLs Are Evolving with More Electronic Promotional…

Untitled Letter Reflects Standards Set in New Major Statement Regulation

OPDP Stresses ‘Public Health’ Concerns in Enforcement Letters

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