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Advertising & Promotion

  • Sep 9, 2019
    Mallinckrodt Announces Tentative Settlement in Opioid Marketing Cases
  • Sep 9, 2019
    Google Bans Ads for Unproven Medical Products
  • Sep 9, 2019
    Texas Files Suit Against J&J Over Patch Marketing; 29 Texas Hospitals File Against Opioid Makers
  • Sep 4, 2019
    South Dakota Adds Three Generic Drug Makers to Opioid Lawsuit
  • Sep 4, 2019
    Second Company Reaches Settlement in Opioid MDL; Ohio AG Seeks To Halt or Delay Trial
  • Aug 27, 2019
    Oklahoma Court Orders J&J To Pay $572 Million To Help Abate Opioid Crisis
  • Aug 27, 2019
    First OPDP Warning Letter of 2019 Focuses on Risk Information
  • Aug 26, 2019
    FTC Sends Out Refunds for ‘Deceptively Marketed’ Dietary Supplements
  • Aug 22, 2019
    HHS Appeals District Court Ruling Stopping Price Disclosures in DTC TV Ads
  • Aug 21, 2019
    OPDP Wants To Hear About Experiences With Third-Party eCTD Submissions
  • More

Good Clinical Practice

  • Oct 4, 2019
    Patients Want To Be Asked About Using De-identified Medical Records for Research
  • Oct 2, 2019
    OIG Says NIH Can ‘Do More’ in Monitoring FCOIs
  • Oct 2, 2019
    Cancer Trial Subject Reimbursement Bill To Be Introduced in Wisconsin Legislature
  • Oct 2, 2019
    SCRS Offers Sites Patient Engagement and Retention Platform
  • Oct 2, 2019
    FDA Issues Draft Guidance on Proposing Complex Innovative Trial Designs
  • Sep 30, 2019
    Number of FDA BIMO Citations Continued to Drop in FY 2018
  • Sep 30, 2019
    FDA Issues Guidance to Aid Patient Engagement in Designing and Conducting Device Trials
  • Sep 30, 2019
    Sponsor-Investigator Receives Warning Letter For Not Following Inclusion Criteria
  • Sep 16, 2019
    EMA Opens Consultation on Pediatric Trial Preparedness
  • Sep 16, 2019
    California Bill Expands Insurance Coverage of Routine Care Costs in Clinical Trials
  • More

U.S. Food Labeling

  • Aug 23,2017
    Food Waste Reduction Bill Would Also Standardize Date Labels
  • Aug 15,2017
    GMA: Consumers Are Confused by Date Labels
  • Aug 15,2017
    House Member Is New Cochair of Dietary Supplement Group
  • Aug 15,2017
    Rule Extends Civil Penalties to COOL Violations
  • Aug 15,2017
    Rulemakings on Bioengineered Food, Revision of Facts Panel Are ’Inactive’
  • Aug 14,2017
    FDA Announces UF Milk, Nonfat Milk Guidance
  • Aug 9,2017
    Bill Would Amend Menu Labeling Rule Before FDA Rule Kicks In
  • Aug 9,2017
    FDA Greenlights Soybean Oil Qualified Health Claim
  • Aug 2,2017
    FDA Approves Macadamia Nut Qualified Health Claim
  • Jul 25,2017
    Salmon Labeling Bill Introduced in Senate
  • More

FDA Regulation & Enforcement

  • May 10, 2023
    Food Label Modernization Bills Introduced in House and Senate
  • May 3, 2023
    Development of cGMP Regulations for Cosmetics Begins With June 1 FDA Listening Session
  • May 2, 2023
    OPDP Researchers Move Ahead With Three Studies
  • May 1, 2023
    FDA Mulls Online Grocery Labeling
  • Apr 26, 2023
    Health Care Firm To Plead Guilty, Pay Over $2.5 Million for Administering Non-U.S. Botox Products
  • Apr 26, 2023
    Citing Express Preemption, Court Dismisses Claims Brought Against Pacemaker Manufacturer by Patient’s Estate
  • 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 20, 2023
    FDA Cites Firm for Recalled Products’ Labeling
  • Apr 19, 2023
    Undercover Drug Buys Lead to Guilty Plea by Idaho Man Who Distributed Over $4.4 Million in SARMs
  • More

Medical Devices

  • Apr 29, 2020
    House Memo Blasts FDA Oversight of 'Inaccurate,’ ‘Potentially Fraudulent’ COVID-19 Antibody Tests
  • Apr 20, 2020
    FDA, NIH, CDC To Collaborate To Validate COVID-19 Virus Antibody Tests: EUA Template in the Works
  • Apr 17, 2020
    FDA Continues To Process Device Applications During COVID-19 Emergency, Extends Response Due Dates
  • Apr 16, 2020
    Coronavirus Diagnostic Testing: What the FDA Expects for LDTs, Commercial Test Kits, Serological Tests
  • Apr 15, 2020
    FDA Extends Enforcement Discretion to Various Types of Medical Devices During COVID-19 Emergency
  • Apr 9, 2020
    Pentax Medical Admits to Criminal Misbranding Charge for Noncompliant IFUs, Failure To File MDRs
  • Mar 31, 2020
    FDA Extends Enforcement Discretion for Sterilizers, Air Purifiers, Gowns, Gloves During COVID-19 Crisis
  • Mar 30, 2020
    FDA Digital Health Policies Offer Leeway for Development of COVID-19 Software and Apps, Agency Says
  • Mar 25, 2020
    CDRH Updates Medical Device Companies on Agency’s Priorities During COVID-19 Outbreak
  • Mar 19, 2020
    Major Regulatory Reform Legislation for In Vitro Diagnostics, Laboratory-Developed Tests Is Introduced
  • More

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