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Advertising & Promotion

  • Feb 7, 2023
    PMCPA Issues UK’s First Guidance on Social Media
  • Jan 29, 2023
    NAD Finds Drug Claim Supported in Physician-Directed Messaging But Not in Consumer-Directed Ads
  • Jan 25, 2023
    DePuy Synthes To Pay $9.75 Million To Resolve Allegations of Providing Free Devices to Surgeon
  • Jan 24, 2023
    Physicians’ Group Files OPDP Complaint Over 60 Minutes’ Wegovy Segment
  • Jan 13, 2023
    Omnibus Spending Act Codifies FDA Guidance on Communications with Payors
  • Jan 6, 2023
    Arizona Sues Drug Maker Over Potency Statements
  • Dec 30, 2022
    FTC Expands Advertising Guide To Include All Health-Related Claims
  • Dec 23, 2022
    Florida Supreme Court Considers Grand Jury Investigation of Manufacturers’ COVID-19 Vaccine Claims
  • Dec 19, 2022
    FDA: Ads for Hypertension Drugs Should Cite Cardiovascular Outcome Claims
  • Dec 15, 2022
    PMCPA Finds Novo Nordisk Breached ABPI Code in Weight Management Course Sponsorship
  • More

Good Clinical Practice

  • Apr 25, 2023
    FDA Debars Former Trial Site Co-Owner
  • Apr 18, 2023
    FDA Now Recommends Risk-Based Monitoring for Clinical Trials
  • Apr 13, 2023
    FDA, OHRP Tell Sponsors How To Navigate Agency Pediatric Research Referrals
  • Mar 31, 2023
    Clinical Investigators Receive Warning Letters Over Lack of IND and Not Following Protocol
  • Mar 24, 2023
    FDA Extensively Revises Clinical Trial Electronic Records Guidance
  • Mar 17, 2023
    Sponsor-Investigator Receives Warning Letter for Failing to Submit an IND
  • Mar 13, 2023
    FDA BIMO Inspections Rebound in FY 2022
  • Mar 9, 2023
    FDA Provides Roadmap for Externally Controlled Trials
  • Mar 1, 2023
    Group Petitions FDA To Improve Enforcement of Trial Reporting Mandates
  • Feb 22, 2023
    GAO Recommends More Oversight of IRBs
  • More

U.S. Food Labeling

  • Jul 7,2022
    National Chicken Council Wants FDA, FSIS To Address Allegedly Misleading Plant-based Product Marketing Claims
  • Jun 23,2022
    Members of Congress Want Changes to Plant-Based Milk Guidance Before Release
  • Jun 9,2022
    Bill Would Create FDA-Managed Dietary Supplement List
  • May 24,2022
    FDA Warns Companies About Selling Violative Supplements
  • May 12,2022
    Draft Guidances Released on NAC as Supplement, How FDA Will Evaluate Non-listed Food Allergens
  • Apr 18,2022
    Survey Finds ‘Organic’ Unclear to Consumers; Antibiotics Found in Cattle Labeled ‘RWA’
  • Apr 14,2022
    FDA Upholds Position That NAC Is Not a Supplement, Promises Enforcement Guidance
  • Mar 31,2022
    FDA Responds to Comments Received on ‘Healthy’ Symbol
  • Mar 17,2022
    Association Continues To Press FDA on Changes to Artificial Sweetener Labeling
  • Mar 4,2022
    District Court Rejects Claims That Food Products’ Labeling of Protein Content Was Misleading
  • More

FDA Regulation & Enforcement

  • Apr 30, 2025
    Doctor Faces Up to Three Years in Prison for Administering Non-FDA-Approved Semaglutide to Patients
  • Apr 25, 2025
    FDA Moves To Remove All Petroleum-Based Dyes From Food
  • Apr 23, 2025
    Florida Man Pleads Guilty to Wire Fraud in Connection With Distribution of Black-Market HIV Drugs
  • Apr 18, 2025
    Menendez Reintroduces Caffeine Labeling Bill
  • Apr 16, 2025
    Study Finds Meat-like Names for Plant-based Products Could Confuse Consumers
  • Apr 16, 2025
    Fifth Circuit: Maker of FDA-Approved Drug May Sue Compounder Under State Unfair Competition Statutes
  • Apr 15, 2025
    Vanda Pharmaceuticals Challenges Constitutionality of FDA's Restrictions on Off-Label Marketing
  • Apr 9, 2025
    Firm To Pay $550K To Resolve False Claims Allegations Linked to Multiple Uses of Single-Use Devices
  • Apr 4, 2025
    OPDP Flags Efficacy Webpage With Untitled Letter
  • Apr 2, 2025
    Diopsys Inc. To Pay Up to $14.25 Million To Resolve False Claims Allegations Involving Vision Testing
  • More

Medical Devices

  • Mar 6, 2024
    Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities
  • Feb 29, 2024
    Citing Data Integrity Concerns, FDA Warns Device Study Sponsors About Fraudulent Lab Testing
  • Feb 21, 2024
    FDA Suggests Only Small Businesses in Bankruptcy May Qualify for Device Establishment Fee Waivers
  • Feb 21, 2024
    CDRH Reorganizes Office of Strategic Partnerships and Technology Innovation Into ‘Super Office’
  • Feb 15, 2024
    AdvaMed Opposes Proposed FTC ‘Right To Repair’ Rulemaking, Citing Safety and Performance Risks
  • Feb 7, 2024
    FDA Announces Initiative To Reclassify High-Risk IVDs To Make Them Eligible for 510(k) Clearance
  • Feb 1, 2024
    Former Device Firm Employee Who Forged FDA 510(k) Clearance Letters Will Serve 12 Months in Prison
  • Jan 31, 2024
    FDA Issues Quality Management System Regulation Final Rule, Incorporating ISO 13485 Standards
  • Jan 25, 2024
    Senators Ask GAO To Review FDA Oversight of Recalls in Wake of Philips Respironics Device Problems
  • Jan 18, 2024
    FDA Offers Guidelines for Third-Party EUA Review, Revises Third-Party 510(k) Review Guidance
  • More

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