All News | FDA

Advertising & Promotion

May 17, 2023
Court Grants Summary Judgment to Device Company Accused of Wrongful Discharge of Sales Rep Over Off-label Marketing
May 2, 2023
OPDP Researchers Move Ahead With Three Studies
Apr 25, 2023
OPDP Researchers Plan Survey on How Consumers Interpret Specific Quantitative Claims
Apr 20, 2023
Court: State Law Claims Involving Class II Device Cleared via De Novo Process Not Expressly Preempted
Apr 15, 2023
FTC Sends Out Nearly 700 Notices of Penalty Offenses on Substantiating Claims
Apr 13, 2023
District Court Dismisses Case Over Abreva Advertising Claims
Apr 5, 2023
FDA Readies Final Guidance on Quantitative Efficacy and Risk Info in DTC Ads
Mar 28, 2023
District Court Dismisses RICO Case Involving Patient Assistance Program
Mar 17, 2023
ABPI Suspends Novo Nordisk Over Sponsored Course Promoted on LinkedIn
Mar 16, 2023
Interviews with Health Care Influencers Find Resistance to Company Messaging

Good Clinical Practice

Sep 13, 2023
What Should IRBs Consider in Reviewing Individual Expanded Access Submissions?
Sep 6, 2023
Clinical Investigator Receives Warning Letter Over Alleged Failure To Follow Protocol
Aug 29, 2023
HHS Issues Draft Scientific Integrity Policy
Aug 21, 2023
FDA Releases Long-Awaited Final Informed Consent Guidance
Aug 6, 2023
WHO Proposes Clinical Trial Best Practices
Jul 31, 2023
SACHRP Makes Recommendations on Draft FDA DCT and OHRP Limited IRB Review Guidances, Adds New Members
Jul 26, 2023
University Receives Determination Letter for Allegedly Not Revising Written IRB Procedures To Reflect Revised Common Rule
Jul 18, 2023
FDA Provides ‘Good Cause’ Reasons for Missing PMR Deadlines
Jul 12, 2023
SEC Charges Former Trial Statistician with Insider Trading
Jun 23, 2023
OHRP Explains Use and Operation of Limited IRB Review

U.S. Food Labeling

Jan 5,2023
FDA, FSIS Set Food Labeling Uniform Compliance Date
Jan 5,2023
FDA Removes Stay on Yogurt Standard of Identity Provisions
Dec 30,2022
FTC Expands Advertising Guide To Include All Health-Related Claims
Dec 22,2022
Agencies Jointly Issue RFI for Input on Regulating Biotechnology
Dec 9,2022
FDA Posts Clarifying Guidances on Food Allergen Labeling, Asks for Comments on 'Milk,' 'Eggs'
Nov 23,2022
Cell Culture Food Gets First FDA Safety Go-Ahead
Nov 10,2022
Court Enjoins Distribution of Adulterated, Misbranded Supplements
Oct 27,2022
FDA Officials Explain Need for ‘Healthy’ Labeling Proposal, FOP Labeling
Oct 12,2022
Poll Results Show Strong Support for MCOOL Labeling for Beef
Sep 29,2022
FDA Proposes Updates to Definition, Nutrient Content Claim for ‘Healthy’

FDA Regulation & Enforcement

Feb 24, 2025
FDA Pushes ‘Healthy’ Claim Final Rule Effective Date to April
Feb 21, 2025
HFP Head Resigns Over ‘Indiscriminate’ Staff Layoffs
Feb 19, 2025
First Circuit Sets High Bar for Establishing False Claims Violations Tied to Kickback Violations
Feb 12, 2025
State Unfair Practices Claim Targeting Prescription Pet Food Is Preempted, District Court Rules
Feb 12, 2025
Senators Ask FDA To Review Compounder’s Super Bowl Ad
Feb 7, 2025
FDA Ponders SOI for High-Protein Yogurt
Feb 5, 2025
Appeals Court Upholds Dismissal of Challenge to HHS OIG Advisory Opinion on Coalition Model PAP
Jan 31, 2025
Sen. Sanders To Reintroduce Food Warning Label Legislation
Jan 29, 2025
Pfizer To Pay Nearly $60 Million To Resolve Kickback Allegations Arising From Subsidiary’s Speaker Programs
Jan 29, 2025
Court Dismisses False Claims Allegations Against IVD Device Maker, Citing Rule 9(b) Particularity

Medical Devices

Copyright © Thompson FDA, a division of CBIS. All rights reserved.