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Advertising & Promotion

  • Jun 15, 2019
    ABPI Issues Guide To Working with Patient Groups
  • Jun 14, 2019
    Senate Bill Would Require Cost Reporting; Provide Funds for Clinical Trials
  • Jun 13, 2019
    ACell Inc.’s Failure To Report Removal of Wound Dressing Product to FDA Leads to $15 Million Settlement
  • Jun 13, 2019
    TGA Issues Guidance on Use of ‘Natural’ in Medical Product Ads
  • Jun 10, 2019
    Senate Bill Imposing Penalties on ‘Dubious’ Opioid Marketing Introduced
  • Jun 10, 2019
    OPDP Research Finds High-Distraction Ads Reduce Consumer Recognition of Risk Info
  • Jun 10, 2019
    CBER Sends Stem Cell Firm Untitled Letter
  • Jun 8, 2019
    U.S. Files Lawsuit Against Mallinckrodt Over Use of Charity Foundation
  • Jun 7, 2019
    Former CEO To Pay $2.5 Million To Settle False Claims Act Case in Florida
  • Jun 7, 2019
    Three States Sue Sackler Family
  • More

Good Clinical Practice

  • Aug 5, 2019
    ACRES Launches Trial Site Accreditation
  • Aug 2, 2019
    FDA Releases ICH Guidance for Comment
  • Aug 2, 2019
    SACHRP Recommends More Guidance on Payments Made to Research Subjects
  • Jul 28, 2019
    ‘Uninformative’ Trials Need To Be Eliminated
  • Jul 25, 2019
    ACRP Partners with SCRS To Provide Online GCP and Ethics Training
  • Jul 19, 2019
    Small Survey Finds Respondents More Willing To Participate in Mobile Trials Than Traditional Trials
  • Jul 18, 2019
    Groups Push for Medicaid Coverage of Routine Care Costs in Clinical Trials
  • Jul 17, 2019
    EC Revises Safety Guidance for Products Used in Clinical Trials
  • Jul 16, 2019
    FDA Proposes Exemptions from eCTD for Some Type III Drug Master Files
  • Jul 15, 2019
    Improvement Needed in Trial Transparency and Data Sharing
  • More

U.S. Food Labeling

  • Mar 9,2017
    New Group Petitions FDA for Final Rule on Use of Certain Terms
  • Feb 28,2017
    Opposition to House, Senate Dairy Labeling Bills Mounting
  • Feb 23,2017
    Judge Denies Motion To Dismiss Case Against Coca-Cola Over Use of 'Evaporated Cane Juice'
  • Feb 14,2017
    5-Hour Energy To Pay More Than $4.3 Million In Penalties Related to False Advertising
  • Feb 14,2017
    Court Rules New York City’s Sodium Rule Can Stand
  • Feb 9,2017
    Association Urges FDA To Issue Sugar Limits on Certain Claims
  • Feb 2,2017
    FDA Warns Tofu Maker for Alleged Misbranding, Citing Cholesterol and Proteint Claims in Labeling
  • Jan 26,2017
    USDA Strengthens Rule for Livestock and Poultry Using Organic Seal
  • Jan 25,2017
    Bill Seeks To Stop Misbranded Milk Alternatives
  • Jan 13,2017
    Coca-Cola Sued Over Deceptive Ads for Sugary Drinks
  • More

FDA Regulation & Enforcement

  • Feb 7, 2023
    PMCPA Issues UK’s First Guidance on Social Media
  • Feb 2, 2023
    FDA Seeks Input on Designing FOP Labeling System
  • Feb 1, 2023
    API Importer and Distributor Enters Into Consent Decree To Resolve Alleged cGMP Violations
  • 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 19, 2023
    FSIS Rule Expands List of Products Qualifying for Generic Label Approval
  • Jan 18, 2023
    New DOJ Criminal Division Policy Offers Additional Incentives To Self-Disclose Wrongdoing
  • Jan 13, 2023
    Omnibus Spending Act Codifies FDA Guidance on Communications with Payors
  • Jan 12, 2023
    Supreme Court Declines To Consider Pfizer's Challenge to HHS Interpretation of Anti-Kickback Statute
  • More

Medical Devices

  • Oct 29, 2019
    FDA Warns of National Shortage of Devices Due to Closures of Ethylene Oxide Sterilization Facilities
  • Oct 24, 2019
    FDA Outlines Proposed Pilot Program for Assessing Devices’ Conformity to Recognized Consensus Standards
  • Oct 21, 2019
    Court: Device Firm Must Give Relator Materials That Were Provided to Government Before DOJ Declined To Intervene
  • Oct 17, 2019
    CDRH Posts FY 2020 Guidance Development Priorities
  • Oct 4, 2019
    First Draft Performance Criteria Covering Four Device Types Released for Alternative 510(k) Pathway
  • Oct 2, 2019
    Revised Guidance Documents Mark Changes in FDA’s Policies for Regulating Digital Health Products
  • Sep 30, 2019
    FDA Issues Guidance to Aid Patient Engagement in Designing and Conducting Device Trials
  • Sep 26, 2019
    Draft FDA Guidance Describes Upcoming Rollout of Electronic Format Requirements for Device Submissions
  • Sep 18, 2019
    Manufacturer, Subsidiary To Pay $9.5 Million To Resolve Liability for Marketing Devices Not Cleared by FDA
  • Sep 18, 2019
    FDA Announces New Program To Help Speed Safer Devices to Market Through Expedited Agency Review
  • More

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