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Advertising & Promotion

  • Aug 29, 2022
    Court Allows Federal FCA Case Against Abbott to Proceed
  • Aug 24, 2022
    Optical Lens Maker To Pay $22 Million To Resolve False Claims Liability Tied to Alleged Kickbacks
  • Aug 22, 2022
    Study Finds DTC Heart Drug Ads Have Little Effect on Lifestyle Intentions
  • Aug 14, 2022
    Risk Info in CSL Communications Aids Consumer Recognition, Study Finds
  • Aug 1, 2022
    FTC Opens Endorsement and Testimonial Guide Revisions for Public Comment
  • Jul 29, 2022
    Device Maker Settles Kickback Allegations
  • Jul 25, 2022
    FDA Issues Warning Letter Over Compounded Drug Claims
  • Jul 15, 2022
    House Bill Would Set Deadline for FDA’s Final Rule on DTC Prescription Drug Ads
  • Jul 8, 2022
    FTC Consent Order Bans Two Companies and Owner from Advertising or Selling Dietary Supplements
  • Jul 1, 2022
    Release of FDA’s Final Rule on DTC Drug Ads Pushed to May 2023
  • More

Good Clinical Practice

  • Oct 28, 2022
    FDA Goes Beyond ICH Advice on Dealing with Multiple Endpoints in Clinical Trials
  • Oct 22, 2022
    SACHRP Counsels FDA on Common Rule Harmonization
  • Oct 14, 2022
    Owners of Another Miami Clinical Site Charged with Data Fabrication
  • Oct 11, 2022
    FDA Details Ethical Considerations for Pediatric Trials
  • Oct 2, 2022
    FDA Proposes Regulations To Harmonize with Revised Common Rule
  • Sep 23, 2022
    OHRP Issues Two Determination Letters
  • Sep 18, 2022
    New Draft Guidance on Clinical Pharmacology Considerations for Pediatric Studies Expands 2014 Guidance
  • Sep 12, 2022
    Work Group Issues Recommendations To Improve Communication with Subjects When Trials End Early
  • Sep 6, 2022
    ORI Opens 'Brainstorming Process' for Research Misconduct Rule Revision
  • Aug 26, 2022
    FDA Provides Additional Answers on Charging for Investigational Drugs
  • More

U.S. Food Labeling

  • Nov 21,2021
    FSIS Extends Comment Period on Labeling Cell Cultured Meat, Poultry
  • Nov 18,2021
    Biden Nominates Dr. Robert Califf To Head the FDA Again as Commissioner of Food and Drugs
  • Nov 10,2021
    FDA Revises Temporary Marketing Permit Guidance To Streamline Process
  • Oct 28,2021
    Supplement Firm Enjoined From Selling Violative Products
  • Oct 14,2021
    FDA Publishes Guidance Setting Voluntary Sodium Reduction Targets for Food
  • Sep 30,2021
    FSIS Revises Guideline on Food Products Packaged as Kits
  • Sep 15,2021
    FSIS Asks for Comments on Cell Cultured Meat, Poultry Labeling
  • Sep 1,2021
    Congress Again Moves To Mandate Updates to Food Labeling
  • Aug 19,2021
    FDA Rejects NDIs for CBD Products Intended To Be Marketed as Dietary Supplements
  • Aug 4,2021
    Courts in Three Separate Product Actions Side With Trader Joe’s
  • More

FDA Regulation & Enforcement

  • Nov 1, 2024
    CBO Finds Eliminating or Limiting DTC Ads Would Result in Very Small Reductions in Drug Prices
  • Oct 30, 2024
    Marketer of Face Masks Misrepresented as N95s, Two Executives Plead Guilty to Misbranding Charges
  • Oct 30, 2024
    Court: Claims Related to a Contraceptive Device Are Barred by Statute of Limitations and Preempted
  • Oct 25, 2024
    Senate HELP Committee To Examine FOP Labeling
  • Oct 23, 2024
    DOJ Obtains Guilty Plea for Online Sales of SARMs That Continued Despite FDA Warning Letter
  • Oct 21, 2024
    JAMA Article Reports Half of Top Journals’ Peer Reviewers Received Industry Payments
  • Oct 16, 2024
    Ninth Circuit Says FDA Can Regulate Stem Cell Clinic Procedure, Reversing Lower Court’s Holding
  • Oct 15, 2024
    Teva $450M Payment Resolves Kickback, False Claims Allegations Linked to Patient Co-Pays, Price Fixing
  • Oct 11, 2024
    OPDP Researchers To Examine Talk Show Drug Promotion; Move Ahead with Adherence and Preference Claims Study
  • Oct 9, 2024
    Vape Company Asks Court To Declare That FDA Civil Money Penalty Proceeding Violates Right to Jury Trial
  • More

Medical Devices

  • Sep 7, 2023
    FDA: Three New Draft 510(k) Guidance Documents Address Increased Complexity of Medical Devices
  • Aug 30, 2023
    Device Maker Calls for Dismissal of False Claims Act Suit, Saying Qui Tam Provisions Are Unconstitutional
  • Aug 24, 2023
    Court Dismisses Ohio Tort Law Claims Brought by Patient Injured by Migrations of Surgical Clips
  • Aug 17, 2023
    CDRH Officials Report Return to Normal Operations, Surge in Device Innovation Following COVID-19
  • Aug 9, 2023
    Neuro Device Manufacturer, CEO Resolve False Claims Allegations Over Medicare Billing Codes
  • Aug 3, 2023
    Increases Announced for Device User Fees in FY 2024
  • 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
  • More

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