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Advertising & Promotion

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
Mar 7, 2023
Permanent Injunctions Entered Against Three Distributors Over Marketing Claims
Feb 28, 2023
FDA Debars Former Chief Executive and Former Medical Director Over Marketing Claims
Feb 22, 2023
CDRH Issues Warning Letter Over Off-label Promotion
Feb 10, 2023
Studies Reveal That Most DTC Advertising Is for Drugs with Low Added Clinical Benefit

Good Clinical Practice

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
Jun 13, 2023
FDA Debars Two Former Trial Coordinators
Jun 11, 2023
FDA Issues Warning Letters to Two Clinical Investigators
Jun 5, 2023
Number of BIMO Inspection Observations Dips Slightly in FY 2022
May 28, 2023
Draft ICH GCP Guideline Looks To Aid Use of New Technology in Clinical Trials
May 14, 2023
FDA Opens Dialogue on Possible Benefits, Harms From Use of AI/ML in Drug Development
May 6, 2023
FDA: Decentralized Trials Still Need Central Location for Records

U.S. Food Labeling

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’
Sep 29,2022
Administration Proposes Labeling Changes as Part of National Food Strategy
Sep 16,2022
District Court Upholds Majority of NBFDS Regulations But Rejects Text Message Disclosure Option
Sep 15,2022
Groups Want FDA To Beef Up Front-of-Package Nutrition Labeling Requirements
Sep 1,2022
Studies Look at Market Effect of Mandated GMO Labeling Under Vermont Law
Aug 18,2022
FDA Finalizes Guidance on Supplements Containing NAC
Jul 30,2022
AMS Proposes Two Additions to List of Bioengineered Foods
Jul 21,2022
Petitioners Ask FSIS To Stop Approving Labels With Animal Raising Claims, Grant Flexibility for Beef Stroganoff Product

FDA Regulation & Enforcement

May 21, 2025
Device Firm CEO Pleads Guilty to Charge of Making False Statements to CMS Regarding Alleged Kickbacks
May 21, 2025
DOJ Revises Criminal Enforcement Policies To Encourage Self-Disclosure of Corporate Wrongdoing
May 20, 2025
Concerns Over Risk Claims Prompt Untitled Letter for Speaker Deck
May 14, 2025
FDA, HHS Launch Deregulation Initiative, Seek Public Input on Outdated, Unneeded Rules, Guidance
May 14, 2025
Assertio Therapeutics Enters Into $3.6M Settlement To Resolve Off-Label False Claims Allegations
May 9, 2025
Gilead Agrees to $202 Million Settlement Over Speaker Program
May 9, 2025
FDA Extends Proposed FOP Rule Comment Period to July 15
May 7, 2025
FDA Announces Intent To Conduct More Unannounced Inspections at Foreign Manufacturing Facilities
May 5, 2025
House-Senate Bills Look To End DTC Ad Tax Deduction
Apr 30, 2025
State Law Claims Brought by Survivors of Victim of Faulty ICD Dismissed on Preemption Grounds

Medical Devices

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