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Advertising & Promotion

  • Oct 27, 2022
    Lower Percentage of OPDP Core Launch Reviews Met 45-Day Goal During FY 2022
  • Oct 20, 2022
    OPDP Researchers Move Ahead with Text Analysis of Proprietary Drug Name Interpretations
  • Oct 12, 2022
    Appeals Court Rejects Missouri Case Over Alleged Marketing Misrepresentation
  • Oct 12, 2022
    EEOC Sues Lilly Over Age Discrimination in Hiring Sales Reps
  • Oct 4, 2022
    OPDP Researchers Plan To Move Forward With Study on Targeted Mechanism of Action Claims
  • Sep 28, 2022
    Biogen Settles False Claims Allegations for $900 Million; Relator To Receive Nearly $250 Million
  • Sep 25, 2022
    OPDP Researchers Plan Two New Studies
  • Sep 18, 2022
    District Court Dismisses Novartis Speaker Program Suit
  • Sep 14, 2022
    Third Circuit Upholds Dismissal of Lanham Act Case
  • Sep 7, 2022
    Bayer Settles Lawsuits Over Allegations of Kickbacks and False Statements
  • More

Good Clinical Practice

  • Jan 18, 2023
    Research Coordinator Sentenced to Three Years in Prison for Lying During FDA Inspection
  • Jan 6, 2023
    Omnibus Spending Act Includes Clinical Trial Mandates
  • Dec 30, 2022
    ICH Proposes Harmonized Protocol Standard
  • Dec 23, 2022
    Investigator Receives Warning Letter Over Failure To Follow Investigational Plan
  • Dec 19, 2022
    CTTI Calls for Embedding Clinical Trials into Clinical Practice
  • Dec 13, 2022
    Analysis Finds Both Under- and Overrepresentation of Demographic Groups in U.S. COVID Trials
  • Dec 8, 2022
    ICH Final Guidance Recommends Uses for Selective Safety Data Collection
  • Nov 30, 2022
    Sponsor-Investigator Issued Warning Letter Over Failure To Submit IND for Combination Product
  • Nov 16, 2022
    FDA Extends Comment Period for Common Rule Harmonization Regulations by One Month
  • Nov 4, 2022
    FDA Details How Sponsors Should Make Expanded Access Policies Public and Available
  • More

U.S. Food Labeling

  • Feb 3,2022
    Online Food Retailers Are Not Satisfying Labeling Requirements
  • Feb 3,2022
    FDA Lists Food Guidances Under Consideration
  • Feb 3,2022
    Bills Introduced in Congress for Date, CBD Food Labeling
  • Feb 3,2022
    FASTER Act Video Is Now Available
  • Jan 18,2022
    FDA Allows Health Claim for Magnesium and Risk of Hypertension, Revokes Identity Standard for French Dressing
  • Jan 6,2022
    Ready or Not, Bioengineered Food Labeling Is Now in Effect
  • Dec 22,2021
    FDA Gives Go-ahead to Peanut Health Claim, Signals Intent To Include Gum Acacia as Dietary Fiber
  • Dec 9,2021
    FDA Is Asking for Input on Use of NAC as Dietary Supplement
  • Nov 21,2021
    Meeting Archive Available on Toxic Elements in Baby Food
  • Nov 21,2021
    Recordings From Food E-Commerce Summit Available
  • More

FDA Regulation & Enforcement

  • Nov 29, 2024
    FSIS Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs
  • Nov 27, 2024
    GAO: Attrition Among FDA Investigator Workforce Hampers Agency’s Ability To Meet Inspection Goals
  • Nov 27, 2024
    Appeals Court Upholds Dismissal of Complaint Alleging Fruit Cup Labeling Was False
  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 20, 2024
    Citing Preemption and Ohio Tort Law, Court Dismisses Claims Related to Cervical Disk Device Failure
  • Nov 20, 2024
    QOL Medical, CEO To Pay $47 Million To Resolve False Claims Allegations Stemming From Free Lab Tests
  • Nov 15, 2024
    OPDP Issues Untitled Letter Over Instagram Post
  • Nov 13, 2024
    Spa Owner Allegedly Performed Thousands of Injections Involving Smuggled, Counterfeit Drugs, Devices
  • Nov 9, 2024
    FDA Looks To Update ‘Healthy’ Claim, Propose FOP Labeling in FY 2025
  • Nov 6, 2024
    Supplier of APIs for Compound Rxs To Pay $21.75M To Settle Allegations of Setting False, Inflated AWPs
  • More

Medical Devices

  • Oct 25, 2023
    FDA Extends Policy Allowing Some Changes to Remote Monitoring Devices Without New 510(k) Submissions
  • Oct 17, 2023
    Additional Guidance on AI/Machine Learning Devices Included in FY 2024 Guidance Development Plan
  • Oct 16, 2023
    Former CEO Pleads Guilty to Marketing Migraine Treatment Device Without FDA’s Authorization
  • Oct 11, 2023
    FDA ‘Unsatisfied’ With Recall of Philips Respironics Devices; Senator Calls for Enforcement Action
  • Oct 1, 2023
    FDA Proposed Rule Would Fully Regulate LDTs as Devices With Phaseout of Enforcement Discretion
  • Sep 27, 2023
    Finalized Cybersecurity Guidance Covers FDORA Mandates, Adds Quality System and TPLC Recommendations
  • Sep 21, 2023
    FDA Finalizes Biocompatibility Recommendations for Devices Using Common Polymers, Natural Fabrics
  • Sep 15, 2023
    GAO Finds Few Studies, Conflicting Opinions on DTC Device Ads
  • Sep 14, 2023
    Breakthrough Designation Can Apply to Devices Addressing Health Inequities Under Updated Guidance
  • Sep 14, 2023
    DOJ Counters Device Maker’s Argument That False Claims Act Qui Tam Suits Violate U.S. Constitution
  • More

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