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Advertising & Promotion

Jul 20, 2023
Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices
Jul 12, 2023
Diagnostics Firm Penalized by SEC for Allegedly Misleading Press Releases About a COVID-19 Test
Jul 10, 2023
FTC Sets Policy on Endorsements
Jul 5, 2023
Final Guidance on Quantitative Efficacy and Risk Info in DTC Promotions Is Little Changed From Draft
Jun 29, 2023
Ex-DePuy Sales Rep Charged With Defrauding Hospital, Lying to FBI About Sterilization Interference
Jun 28, 2023
Connecticut To Require Companies With Sale Reps To Register
Jun 13, 2023
OPDP Issues First Enforcement Letter in a Year
Jun 6, 2023
FDA Proposes One-Page Patient Medication Information Notice
May 21, 2023
Study Finds Responses to Drug Ads May Be ‘Overly Optimistic’ Without Disclosures
May 17, 2023
Court Grants Summary Judgment to Device Company Accused of Wrongful Discharge of Sales Rep Over Off-label Marketing

Good Clinical Practice

Nov 21, 2023
Investigator Is Issued Warning Letter Over Randomization Concerns
Nov 10, 2023
FDA To Continue Remote BIMO Inspections
Nov 6, 2023
FDA Warning Letter Cites Investigator Over Subject Eligibility and Case Histories
Oct 27, 2023
NIH Requests Information on Consent Requirements for Using Digital Health Tech in Research
Oct 25, 2023
FDA Outlines How It Conducts Remote Interactive Evaluations of Drug and Bioresearch Facilities
Oct 18, 2023
CDER Seeks Opinions on Innovative Trial Approaches
Oct 7, 2023
Two Investigators Receive Warning Letters Over Trial Concerns
Sep 26, 2023
FDA Offers Recommendations on How To Deal With Major Trial Disruptions
Sep 20, 2023
CVM Offers Informed Consent Guidance
Sep 13, 2023
What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?

U.S. Food Labeling

Apr 20,2023
FDA Cites Firm for Recalled Products’ Labeling
Apr 5,2023
FDA Releases Draft Guidance on Using Dietary Guidance Statements on Labels
Mar 23,2023
FDA Stands Firm on Not Allowing CBD as Dietary Supplement
Mar 23,2023
Second Cell Cultured Food Is Given Safety Greenlight
Mar 23,2023
FDA Allows Cocoa Flavanol Qualified Health Claim
Mar 10,2023
USDA Proposes To Regulate ‘Made in USA’ Label Claim To Better Align With Consumer Perceptions
Mar 2,2023
Draft Guidance Allows Use of ‘Milk,’ Recommends Nutrition Information on Plant-Based Product Labeling
Feb 16,2023
USDA Strengthens Enforcement of Organic Rules
Feb 2,2023
FDA Seeks Input on Designing FOP Labeling System
Jan 19,2023
FSIS Rule Expands List of Products Qualifying for Generic Label Approval

FDA Regulation & Enforcement

Mar 21, 2025
State Legislatures Consider Bills That Would Ban DTC Ads
Mar 19, 2025
Ice Cream Manufacturer Enters Into Consent Decree Following cGMP Violations, Discovery of Pathogen
Mar 17, 2025
CVM Issues First Advertising Warning Letters of 2025
Mar 12, 2025
Court Grants Summary Judgment to Allergan on Kickback-Based False Claims, Off-Label Allegations
Mar 7, 2025
Alleged Lack of Risk Info on Exhibit Panel Nets Untitled Letter
Mar 5, 2025
Two Former Magellan Executives Enter Plea Agreements Related to Blood Lead Level Test Malfunctions
Mar 4, 2025
Fig Bar Label Case Continues Over Use of ‘Wholesome’
Mar 1, 2025
Senators Reintroduce Bill That Would Regulate Influencers’ Drug Posts
Feb 26, 2025
Court Dismisses Failure-To-Warn Claim in Wrongful Death Suit Brought Against Drug Manufacturer
Feb 24, 2025
FDA Pushes ‘Healthy’ Claim Final Rule Effective Date to April

Medical Devices

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