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Advertising & Promotion

  • Jun 2, 2022
    Pfizer Reaches Kansas Settlement Over Co-pay Coupon Program
  • May 26, 2022
    Analysis Finds Drug Ad Spending Stagnant Since 2018
  • May 12, 2022
    Revised AdvaMed Code on Interactions with HCPs Becomes Effective June 1
  • Apr 29, 2022
    OPDP Researchers Will Conduct Tradeoff Analysis of Product Claims Made to Consumers and Physicians
  • Apr 18, 2022
    Marketers Sentenced for Roles in Compounded Drug Kickback Scheme Through Oklahoma Pharmacy
  • Apr 18, 2022
    District Court Dismisses Case Against Merck over Vaccine Marketing
  • Apr 13, 2022
    OPDP Issues Untitled Letter Over DTC Video, Efficacy Webpage
  • Apr 6, 2022
    Texas AG Sends Civil Investigative Demands to Two Drug Makers Over Promotion of Hormone Blockers
  • Mar 30, 2022
    FDA, FTC File Joint Complaint for Injunction Against Makers of Herbal Tea Marketed as COVID-19 Cure
  • Mar 25, 2022
    OPDP Will Continue Research Examining Accelerated Approval Disclosures on DTC Websites
  • More

Good Clinical Practice

  • Jul 13, 2022
    AdvaMed Report Recommends Strategies for Boosting Diversity in Medical Technology Clinical Research
  • Jul 8, 2022
    OHRP Issues Draft Guidance on Use of Single IRB for Cooperative Research
  • Jul 1, 2022
    HBCU-Pharma Project Will Create Clinical Trial Centers of Excellence
  • Jun 27, 2022
    HHS To Revise Research Misconduct Regulation
  • Jun 21, 2022
    Researchers: Most Randomized Trials Are Methodologically Flawed
  • Jun 16, 2022
    Investigator Receives Warning Letter Over Alleged Failure To Follow Investigational Plan
  • Jun 9, 2022
    FDA, EMA GCP Inspections Are Finding the Same Deficiencies
  • Jun 2, 2022
    Bill To Boost NIH Trial Diversity Introduced in House
  • May 21, 2022
    National Academies Report Calls for ‘Urgent Action’ on Trial Diversity
  • May 19, 2022
    FDA Denies Citizen Petition Calling for Disqualification of IRB and Two Sponsor-Investigators
  • More

U.S. Food Labeling

  • Apr 29,2021
    FASTER Act Is Now Law; Adds Sesame to List of Major Allergens for Labeling
  • Apr 15,2021
    Appellate Court Will Not Enjoin Missouri Meat Labeling Law
  • Apr 15,2021
    FDA Offers Plan To Reduce Amount of Heavy Metals in Baby Food
  • Apr 1,2021
    Legislation Introduced to Reduce Heavy Metals in Baby Food
  • Apr 1,2021
    AMS Proposes Changes to Organic Substances List
  • Apr 1,2021
    Court Sides With USDA in Suit Questioning Its Position on Hydroponics
  • Apr 1,2021
    Consumer Groups Want FDA To Act Quickly Against ‘Fortified’ Beer
  • Mar 17,2021
    Senate Unanimously Passes Bill To Add Sesame to List of Major Allergens
  • Mar 4,2021
    Class Action Suits Call for Labeling and Reduction of Heavy Metals in Baby Foods
  • Feb 18,2021
    Firms Agree to Discontinue Marketing Claims in Response to NAD Recommendations
  • More

FDA Regulation & Enforcement

  • Jan 10, 2025
    FDA Allergen Labeling Guidance Expands Interpretation of 'Milk,' 'Eggs'
  • Jan 8, 2025
    Athira To Pay Over $4 Million To Resolve False Claims Allegations Stemming From Research Misconduct
  • Jan 5, 2025
    FDA Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs
  • Jan 5, 2025
    Senators Want Payments to Advocacy Organizations Made Public
  • Jan 1, 2025
    Manufacturer and Its President Plead Guilty to FD&C Act Violations in Marketing of Adulterated Fruit Juice
  • Dec 21, 2024
    FDA’s Human Foods Program Sends Warning Letter Over Cookie Labeling
  • Dec 21, 2024
    FDA Updates ‘Healthy’ Claim, Says FOP Proposal Out Soon
  • Dec 18, 2024
    McKinsey To Pay $650 Million To Resolve Liability for Consulting Work Performed for Purdue Pharma
  • Dec 14, 2024
    Senate Hearing Focuses on FOP and Other Labeling Issues
  • Dec 11, 2024
    Biopharma, Clinical Research Executives Convicted on Charges Related to Scheme To Deceive Investors
  • More

Medical Devices

  • Jul 26, 2023
    Former Regulatory Affairs Employee Pleads Guilty to Faking FDA 510(k) Clearances for Two Devices
  • Jul 20, 2023
    Review Finds Discrepancies Between Clearance Documentation and Marketing for Some ‘Smart’ Devices
  • Jul 19, 2023
    District Court: Failure-To-Warn Claim Survives Federal Preemption in Filshie Clip Litigation
  • Jul 12, 2023
    Diagnostics Firm Penalized by SEC for Allegedly Misleading Press Releases About a COVID-19 Test
  • Jul 12, 2023
    Trade Associations Want FDA To Provide More Guidance on Change Plans for AI-Enabled Devices
  • Jul 6, 2023
    Commenting on EPA’s EtO Proposals, AdvaMed Warns of Disruptions at Device Sterilization Facilities
  • Jun 29, 2023
    FDA: Pilot Program for Oncology Drugs Used With In Vitro Tests May Boost Reliability of Some LDTs
  • Jun 29, 2023
    Ex-DePuy Sales Rep Charged With Defrauding Hospital, Lying to FBI About Sterilization Interference
  • Jun 13, 2023
    Guidance Finalizes FDA’s Recommendations for Premarket Submissions for Device Software Functions
  • Jun 12, 2023
    AdvaMed Urges Public, Private Action To Boost the Resilience of the Medical Technology Supply Chain
  • More

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