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Advertising & Promotion

  • Apr 3, 2024
    Former Device Execs Ask Supreme Court To Review Their Convictions for Alleged Off-Label Marketing
  • Mar 27, 2024
    Court Dismisses Kickback Case Against Allergan, Allows Plaintiffs To Amend Complaint
  • Mar 18, 2024
    CVM Issues Warning Letter Over Alleged Claims Made for New Animal Drug
  • Mar 5, 2024
    NJ Appeals Court Dismisses Cases Alleging Unlawful Marketing
  • Feb 20, 2024
    Drug Manufacturer To Pay $750,000 To Resolve Allegations of Paying Indirect Kickbacks to Doctor
  • Feb 19, 2024
    Senators Want FDA Action on Social Media Drug Promotions
  • Feb 9, 2024
    Bill To Ban Advertisement of Drugs Directly to the Public Introduced in Kentucky House
  • Feb 2, 2024
    Advertising Agency Settles Litigation With States Over Opioid Marketing
  • Jan 23, 2024
    OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus
  • Dec 27, 2023
    FDA Issues Guidance To Clarify Major Statement Final Rule
  • More

Good Clinical Practice

  • Jun 7, 2024
    FDA Provides Best Practices for Responding to BIMO Inspection 483s
  • May 29, 2024
    HHS OIG Finds NIH Has ‘Limited Success’ With Expanding Trial Inclusion
  • May 10, 2024
    Controlled Drug Theft Leads to Investigator Warning Letter
  • May 3, 2024
    OMB Adds MENA to Race and Ethnicity Reporting Categories
  • Apr 26, 2024
    FDA Issues Cancer Trial Guidance on Lab Values, Performance Status, Washout Periods and Concomitant Medications
  • Apr 22, 2024
    WHO Details Benefits and Risks of Using AI in Drug Development
  • Apr 15, 2024
    National Academies Recommend Use of PREA and BPCA as Models for Studies Involving Pregnant and Lactating Women
  • Apr 5, 2024
    GAO: FDA Needs To Improve Recruitment and Retention of BIMO Investigators
  • Mar 30, 2024
    NY Psychiatric Institute IRB and Investigator Are Issued Warning Letters
  • Mar 22, 2024
    Senate White Paper Proposes HIPAA Overhaul
  • More

U.S. Food Labeling

  • Jan 17,2024
    GAO Calls for More FDA Oversight of Dietary Supplements
  • Jan 11,2024
    FDA Holds Off on Calculating %DV of Nontraditional Sugars
  • Dec 27,2023
    Fischer Reintroduces Real MEAT Act in Senate
  • Dec 18,2023
    FDA Updates Menu Labeling Guidance Regarding Added Sugars and TPP Nutrition Info
  • Dec 8,2023
    Sugarcane Variant Added to Bioengineered Foods List
  • Dec 4,2023
    FDA Gets Earful on Front-of-Package Labeling
  • Nov 29,2023
    FDA Guidance Clarifies Yogurt Labeling Requirements
  • Nov 6,2023
    CFSAN Updates Its Online Submission Module
  • Oct 23,2023
    FDA Moving Ahead With FOPL Priority
  • Oct 10,2023
    Can a Brand Name Deceive Consumers?
  • More

FDA Regulation & Enforcement

  • Sep 9, 2025
    FOPL Final Rule Expected in May 2026
  • Sep 5, 2025
    Appeals Court Upholds Dismissal of Whistleblower Retaliation Case
  • Sep 4, 2025
    DOJ: False Claims Qui Tam Suits Are Constitutional; Off-Label Marketing Alone Does Not Violate Statute
  • Sep 3, 2025
    Kimberly-Clark To Pay Up to $40.4M for Selling Modified Surgical Gowns Without New 510(k) Clearance
  • 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 26, 2025
    CRS Report Provides Options for Congress on Food Labeling
  • Aug 21, 2025
    SpineFrontier CEO Dodges Prison Term on False Statements Charge Related to Alleged Kickback Scheme
  • Aug 20, 2025
    Citing Preemption, Court Rejects Claims Brought Against Defibrillator Maker Following Patient Death
  • Aug 15, 2025
    USDA Survey Examines Competing and Complementary Claims on Milk, Yogurt Product Packaging
  • More

Medical Devices

  • Dec 18, 2024
    Device Trade Associations Weigh In on FDA’s Guidance Development Priorities for Fiscal Year 2025
  • Dec 11, 2024
    CDRH Provides Early Alert of Potentially High-Risk Device Recall Under Pilot Program
  • Dec 4, 2024
    Final Guidance on PCCPs for AI-Enabled Software Expands Info on Labeling, Postmarket Surveillance
  • Nov 26, 2024
    Enforcement Discretion Policy Can Help Device Firms Facing Potential EtO Sterilization Restrictions
  • Nov 25, 2024
    Trump Names Dr. Marty Makary To Lead FDA
  • Nov 20, 2024
    Citing Preemption and Ohio Tort Law, Court Dismisses Claims Related to Cervical Disk Device Failure
  • Nov 13, 2024
    Associations File Amicus Briefs in Suit Challenging FDA Final Rule on Laboratory Developed Tests
  • Nov 6, 2024
    Medtronic Enters Into Settlement With Health Center That Alleged Bias in Pulse Oximeter Inaccuracies
  • 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
  • More

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