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Advertising & Promotion

  • Dec 8, 2018
    Actelion To Pay $360 Million To Settle Kickback Case Involving Payments to Charitable Foundation
  • Dec 7, 2018
    State AGs File Amicus Brief in Merck Case
  • Dec 7, 2018
    Covidien Settles FCA Case Over Registry
  • Dec 5, 2018
    ev3 Inc. Pleads Guilty to Adulteration Charge Related to Off-Label Promotion of Neurovascular Device
  • Dec 5, 2018
    FTC Settles False Claims Case Against Nobetes
  • Dec 4, 2018
    Industry Group Calls for FDA Guidance on Communications About Biosimilar Products
  • Dec 1, 2018
    Philadelphia Considers Sales Rep Registration and Gift Ban
  • Nov 29, 2018
    Former Insys VP of Sales Pleads Guilty
  • Nov 19, 2018
    Grassley, Durbin Request GAO Examination of DTC Ads’ Impact on Medicare Spending
  • Nov 15, 2018
    FDA Moving Ahead with Research on Scientific and Clinical Data Disclosures for Oncology Promotions
  • More

Good Clinical Practice

  • Feb 11, 2019
    EDPB Opinion Details Interrelationship Between EU’s Clinical Trial and Data Protection Rules
  • Feb 10, 2019
    OHRP Cites Columbia for Not Reporting Inadvertent Release of Subjects’ Email Addresses
  • Feb 7, 2019
    FDA Issues Draft Guidance on EoE Trials
  • Feb 7, 2019
    FDA Issues Final Guidance on Trial Design Issues for Depot Buprenorphine Products
  • Feb 1, 2019
    Bill on Sale of HIPAA Data Introduced in Oregon Senate
  • Jan 31, 2019
    Payments to Subjects May Lead to Eligibility Deception
  • Jan 30, 2019
    FDA Again Delays eCTD Format for Type III DMFs
  • Jan 29, 2019
    Gottlieb Details FDA Plans for Real World Evidence
  • Jan 29, 2019
    UK Publishes Contingency Legislation in Case There Is No Brexit Agreement with EU
  • Jan 26, 2019
    British Universities Failing to Report Trial Results
  • More

U.S. Food Labeling

  • Jun 7,2015
    Canada and Mexico Seek $3.15 Billion In Sanctions Over COOL Ruling
  • Jun 1,2015
    Draft Guidance Covers Labeling Issues That Can Trigger a Mandatory Recall
  • May 22,2015
    Senators Ask FDA To Delay Menu Labeling Deadline for One Year To Aid Small Businesses
  • May 21,2015
    WTO Shoots Down U.S. Appeal To Maintain COOL Labeling Rules
  • May 18,2015
    USDA Expands Ingredient Verification Program To Accommodate Non-GMO Labeling Claims
  • May 14,2015
    Food Industry Appeals Judge’s Decision in Vermont GMO Labeling Suit
  • May 7,2015
    CFSAN Untitled Letters Fault Importers Over Missing Packing Period Codes
  • Apr 30,2015
    Crackdown on Supplements Using Stimulants Continues With 14 Warning Letters Over DMBA
  • Apr 24,2015
    FDA Cracks Down on Workout Supplements Claiming Amphetamine-like Substance as ‘Dietary Ingredient’
  • Apr 23,2015
    Vermont Adopts Final Rule Mandating GMO Labeling by July 2016
  • More

FDA Regulation & Enforcement

  • Apr 6, 2022
    Texas AG Sends Civil Investigative Demands to Two Drug Makers Over Promotion of Hormone Blockers
  • Mar 31, 2022
    FDA Responds to Comments Received on ‘Healthy’ Symbol
  • 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
  • Mar 24, 2022
    Supplement cGMP, Labeling, Product Claim Violations Over Six Years Lead to Consent Decree
  • Mar 17, 2022
    Jury Recommends Nearly $45 Million in Damages in False Advertising Case
  • Mar 17, 2022
    FDA Issues 518(a) Order Requiring Philips To Fix ‘Inadequate’ Device Recall Notification Program
  • Mar 17, 2022
    OIG: Device Firm’s Cost-Sharing Subsidies for Clinical Study Would Pose Only Minimal Risk of Fraud
  • Mar 17, 2022
    Association Continues To Press FDA on Changes to Artificial Sweetener Labeling
  • Mar 9, 2022
    Mallinckrodt To Pay $260 Million To Resolve Medicaid Rebate, Medicare Co-Pay Allegations
  • More

Medical Devices

  • Feb 21, 2018
    FDA’s Combination Products Office Releases Guidance on Preparing a Pre-Request for Designation
  • Feb 15, 2018
    AdvaMed Offers Hit List of FDA Rules in Response to Administration’s Call for Regulation Review
  • Feb 1, 2018
    FDA Issues Updated Versions of Acceptance and Refusal Guidance for 510(k), PMA Submissions
  • Jan 30, 2018
    Advocate of Laser Devices Touted as Treatment for Hundreds of Diseases Pleads Guilty to Federal Charges
  • Jan 25, 2018
    Moratorium on Medical Device Excise Tax Extended for Two Years Under Federal Government Funding Deal
  • Jan 23, 2018
    FDA Works To Speed Product Recall Information to the Public, Outlines Recommendations for Public Warnings
  • Jan 17, 2018
    Proposed Rule Would Establish Procedures, Time Frames for Supervisory Review of CDRH Decisions
  • Jan 12, 2018
    UDI Guidance Outlines Expanded Enforcement Discretion for Class I, Unclassified Medical Devices
  • Jan 11, 2018
    FDA Updates Guidance To Include New Device Accessory Classification Request Pathways
  • Jan 3, 2018
    CDRH Pilot Program To Substitute Quality Appraisals for Routine FDA Inspections of Participating Companies
  • More

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