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Advertising & Promotion

  • Oct 3, 2025
    OPDP Issues Untitled Letter Over Major Statement Presentation
  • Sep 26, 2025
    FDA DTC Promotion Crackdown Continues With Seven Warning Letters
  • Sep 19, 2025
    CDER Posts 40 DTC Advertising Untitled Letters
  • Sep 15, 2025
    CBER Issues First Promotional Warning Letter Since 2016
  • Sep 10, 2025
    FDA Moves To Crack Down on Misleading Drug Ads
  • Sep 5, 2025
    Appeals Court Upholds Dismissal of Whistleblower Retaliation Case
  • Sep 3, 2025
    Appeals Court Upholds Dismissal of Lawsuit Over Promotional Slogan
  • Aug 28, 2025
    Ninth Circuit Upholds Oregon Law Requiring Disclosure of Cost, Price Info About Prescription Drugs
  • Aug 13, 2025
    Texas Accuses Lilly of Incentivizing Providers With Illegal Kickbacks Offered Through Two Programs
  • Jul 23, 2025
    Janssen’s Appeal of $1.64B Off-Label Judgment Includes Constitutional Challenge to False Claims Act
  • More

Good Clinical Practice

  • Oct 3, 2025
    FDA Issues Six Draft Guidances for Specific Disease Trials
  • Sep 26, 2025
    FDA Regs' Harmonization with Revised Common Rule Expected Soon
  • Sep 12, 2025
    Clinical Investigators Receive FDA Warning Letters Over Protocol Adherence
  • Sep 3, 2025
    UK To Launch Pilot Program To Speed Approval of Trial Changes
  • Aug 26, 2025
    AAMC Finds NIH Research Grants Down by Nearly $5 Billion
  • Aug 21, 2025
    FDA Issues Two Draft Oncology Trial Guidances Focusing on Survival Assessments and Radiopharmaceutical Dosage
  • Aug 11, 2025
    DOD Expands TRICARE Clinical Trial Coverage
  • Aug 7, 2025
    NIH Revises Inclusion Policy To Reflect Executive Order
  • Jul 25, 2025
    FDA Pushes Selective Safety Data Collection
  • Jul 11, 2025
    Warning Letter Alleges Investigator Overdosed Two Pediatric Subjects
  • More

U.S. Food Labeling

  • Aug 15,2025
    USDA Survey Examines Competing and Complementary Claims on Milk, Yogurt Product Packaging
  • Aug 10,2025
    Bill To Standardize Food Date Labels Introduced in Senate
  • Aug 7,2025
    Proposed Front-of-Package Labeling Rule Produces Over 13,000 Comments
  • Jul 25,2025
    Agencies Release RFI on Definition of Ultra-Processed Food
  • Jul 18,2025
    FDA Again Encourages Manufacturers To End Use of FD&C Red No. 3
  • Jul 11,2025
    FDA Issues Educational Material To Boost Understanding of NDIN Process
  • Jul 5,2025
    FDA Updates Staff Instructions on Food Labeling Requirements
  • Jun 25,2025
    Amazon Must Face Suit Alleging That It Marketed Dietary Supplements Without FDA-Required Disclaimers
  • Jun 25,2025
    Texas To Require Warning Labels for Foods Containing Artificial Colors, Additives
  • Jun 6,2025
    Study Finds Increased Consumer Use of Nutrition Facts Labels
  • More

FDA Regulation & Enforcement

  • Feb 11, 2026
    Court Refuses To Dismiss Drug Compounder’s Suit Seeking To Have Two FDA Warning Letters Rescinded
  • Feb 7, 2026
    Human Foods Program Releases Priorities for 2026
  • Feb 4, 2026
    Enviro Groups Ask Court To Invalidate Trump EtO Emissions Control Exemptions for Device Sterilizers
  • Feb 4, 2026
    Quality Management System Device Inspections Will Focus on Risk Under New Compliance Program
  • Jan 30, 2026
    FDA Sends Second Untitled Letter Over Nasal Spray’s DTC Ad
  • Jan 30, 2026
    States Legislatures Ponder Food Labeling Bills
  • Jan 28, 2026
    Appeals Court Revives Claims That Medical Product Firms Aided Terrorism With Bribes, Free Products
  • Jan 28, 2026
    HHS OIG Gives Green Light to Proposed Waiver of Co-Payments for Colorectal Cancer Screening Test
  • Jan 26, 2026
    Oklahoma Bill Would Ban DTC Prescription Drug Ads
  • Jan 23, 2026
    FDA Opens Request for Information on Gluten Labeling
  • More

Medical Devices

  • Dec 3, 2025
    FDA Drafts Recommendations for Where To Submit Master Files for Review by Multiple Agency Centers
  • Nov 26, 2025
    Industry, Members of Congress Critique Medicare Competitive Bidding Proposal for Diabetes Devices
  • Nov 19, 2025
    Aesculap Implant Systems Enters Into $38.5M False Claims Settlement, Non-Prosecution Agreement
  • Nov 19, 2025
    House Bill Would Authorize Nonvisual Accessibility Standards for Home Device User Interfaces
  • Nov 12, 2025
    Revised Guidance on Pre-Requests for Designation Updates Process for Obtaining Agency Feedback
  • Nov 5, 2025
    Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg
  • Oct 29, 2025
    CEO Avoids Prison Time for Misbranding Conviction Linked to Devices’ Blood Lead Level Reading Errors
  • Oct 29, 2025
    FDA Warns of Possible ‘Serious Complications’ Resulting From Use of RF Microneedling Devices
  • Oct 22, 2025
    CDRH Expands Early Alert Program for High-Risk Product Recalls To Include All Device Types
  • Oct 15, 2025
    Trade Groups See Inconsistencies Between Regs and Draft Guidance on UDIs for Combination Products
  • More

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