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Advertising & Promotion

  • Mar 5, 2019
    N.Z. Survey Finds Adults with Unhealthier Lifestyles More Responsive to DTC Ads
  • Mar 5, 2019
    Survey Finds Public Support for Listing Prices in Drug Ads
  • Mar 5, 2019
    Appeals Court Remands Dietary Supplement Marketing Case To District Court
  • Mar 5, 2019
    Novartis Sues Janssen Over Advertising Claims
  • Mar 5, 2019
    OPDP Issues First Enforcement Letter for 2019
  • Mar 4, 2019
    FDA Emphasizes Product Communications
  • Mar 1, 2019
    Sales Rep Pleads Guilty Over Kickbacks
  • Feb 27, 2019
    TGA Improves Ad Complaint Database
  • Feb 27, 2019
    FTC Approves Final Order Over iV Cocktail Claims
  • Feb 25, 2019
    Senate Finance Leaders Question Insulin Price Increases
  • More

Good Clinical Practice

  • Apr 8, 2019
    Court Orders Journal Publisher To Pay $50.1 Million Over FTC Charges of Deceptive Practices, High Fees
  • Apr 8, 2019
    Right-to-Try Introduced in Rhode Island House Includes Provision To Continue Investigational Use
  • Apr 6, 2019
    FDA Revises Instructions for Form FDA 1571
  • Apr 5, 2019
    Health Canada Implements ICH GCP Guidance
  • Apr 3, 2019
    Survey Finds Few Patients Speak with Healthcare Professionals About Clinical Trial Participation
  • Apr 2, 2019
    PCORI Research Reporting Process May Be Model
  • Apr 1, 2019
    House Bill Introduced Directing Comptroller General To Study Cancer Trial Participation
  • Mar 30, 2019
    FDA Encourages Expanded Access for Trial Subjects
  • Mar 28, 2019
    Recommendations Released on Conducting Complex Clinical Trials in the European Union
  • Mar 27, 2019
    Survey Finds Two-thirds of Top Research Universities Failed To Post Trial Results
  • More

U.S. Food Labeling

  • Mar 3,2016
    Comment Period on Proposed Gluten-free Labeling Rule Extended
  • Feb 25,2016
    House Passes Legislation To Amend Menu Labeling Requirements
  • Feb 24,2016
    Dr. Robert M. Califf Confirmed by Senate as New Commissioner of Food and Drugs
  • Feb 18,2016
    Sugar Groups Prod FDA on Misuse of 'Maple' Labeling Claims
  • Feb 11,2016
    BJ’s Wholesale Club Recalls Deli Meats
  • Feb 4,2016
    Undeclared Ingredients Lead to Recall of Several Tomato-based Products
  • Jan 28,2016
    Sen. Sanders, Others Question GMA Proposed QR Code Labeling Initiative
  • Jan 21,2016
    Nearly 30,000 Pounds of Misbranded Sausage Recalled
  • Jan 14,2016
    Campbell Soup Joins Push for National GMO Labeling Standard
  • Jan 7,2016
    Comment Period on ‘Natural’ Food Labeling Extended
  • More

FDA Regulation & Enforcement

  • Aug 1, 2022
    Appeals Court Affirms Rejection of Pfizer’s Challenge to HHS OIG Advisory Opinion on Drug Co-Pays
  • Aug 1, 2022
    Court Dismisses False Claims Case in Which DOJ Suggested Liability Could Be Based on FD&C Violations
  • Aug 1, 2022
    FTC Opens Endorsement and Testimonial Guide Revisions for Public Comment
  • Jul 30, 2022
    AMS Proposes Two Additions to List of Bioengineered Foods
  • Jul 29, 2022
    Device Maker Settles Kickback Allegations
  • Jul 25, 2022
    Draft Guidance Signals That Remote Regulatory Assessments Are Now a Permanent FDA Enforcement Tool
  • Jul 25, 2022
    FDA Issues Warning Letter Over Compounded Drug Claims
  • Jul 21, 2022
    Petitioners Ask FSIS To Stop Approving Labels With Animal Raising Claims, Grant Flexibility for Beef Stroganoff Product
  • Jul 20, 2022
    Proposed Repeal of Methods of Analysis Rule Would Give FDA More Flexibility in Enforcement Actions
  • Jul 15, 2022
    House Bill Would Set Deadline for FDA’s Final Rule on DTC Prescription Drug Ads
  • More

Medical Devices

  • Nov 21, 2018
    CDRH Report Highlights Link Between Increased Enforcement Activity and Stepped-Up Compliance
  • Nov 14, 2018
    Kentucky Appeals Court Affirms Dismissal of State Law Tort Claims Against Maker of Class III IDE Device on Preemption Grounds
  • Nov 5, 2018
    FDA Carves Out Periods of Targeted Enforcement Discretion for Some Devices’ UDI Requirements
  • Nov 1, 2018
    AdvaMed Advocates Three New Anti-Kickback Statute Safe Harbors To Help Advance Value-Based Care
  • Oct 24, 2018
    FDA Hopes To Streamline 510(k) Review for Optical Coherence Tomography Devices Through Pilot Program
  • Oct 18, 2018
    Updated FDA Draft Guidance Shows How To Address Cybersecurity Threats in Premarket Submissions
  • Oct 10, 2018
    OIG Report May Prompt Changes in FDA’s Review of Cybersecurity Issues in Submissions for Networked Devices
  • Oct 4, 2018
    CDRH Releases Device Guidance Development Plan for FY 2019, Calls for Stakeholder Comment
  • Oct 1, 2018
    FDA Proposes Expansion of Special 510(k) Eligibility with Draft Guidance, Pilot Program
  • Sep 28, 2018
    CDRH Reopens 10-Year-Old Draft Guidance on Trials for Coronary Drug-Eluting Stents
  • More

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