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Advertising & Promotion

  • Nov 14, 2021
    OPDP Researchers Plan Second Look at Proprietary Names
  • Nov 6, 2021
    California, Oklahoma Courts Find for Manufacturers in Opioid Marketing Cases
  • Oct 29, 2021
    Arizona Settles with Three Physicians Over Insys Speaker Program
  • Oct 28, 2021
    OPDP Researchers To Examine Influence of Targeted Mechanism of Action Claims, Graphics and Disclosures
  • Oct 21, 2021
    FTC Puts Industry on Notice About Endorsements
  • Oct 14, 2021
    FDA Develops Quiz To Promote Bad Ad Program
  • Oct 7, 2021
    Three Advertising and Communication Guidances Gain OMB Information Collection Approval
  • Sep 30, 2021
    Former Insys Sales Rep Pleads Guilty to Fraud Conspiracy Charge Arising From Sham Speaker Program
  • Sep 30, 2021
    Teva Settles Opioid Claims with Louisiana
  • Sep 17, 2021
    Endo Settles New York Cases Involving Opioid Marketing
  • More

Good Clinical Practice

  • Jan 7, 2022
    Clinical Investigator Is Issued Warning Letter over Record Retention
  • Dec 31, 2021
    FDA: DHTs Hold Promise But Also Risks for Clinical Trials
  • Dec 24, 2021
    Clinical Investigator Charged with Insider Trading
  • Dec 17, 2021
    HHS, FDA Announce Plans for Clinical Trial Rule Changes
  • Dec 14, 2021
    FDA Final Guidance on Pediatric Studies of Anti-infective Products Adds Recommendations on Safety Data
  • Dec 3, 2021
    OIG Opinion OKs Sponsor Picking Up Medicare Beneficiary Costs in Clinical Trial
  • Nov 30, 2021
    FDA Debars Trial Site Receptionist
  • Nov 19, 2021
    Public Citizen Calls for Disqualification of Two Investigators and IRB
  • Nov 18, 2021
    Biden Nominates Dr. Robert Califf To Head the FDA Again as Commissioner of Food and Drugs
  • Nov 17, 2021
    FDA, NIH Need To Do More To Ensure Trial Result Reporting: JAMA Viewpoint
  • More

U.S. Food Labeling

  • Aug 17,2020
    FDA Publishes Rule for ’Gluten-Free’ Labeling of Fermented, Hydrolyzed Foods
  • Aug 6,2020
    AMS Releases Proposal To Buttress NOP Enforcement, Improve Traceability
  • Jul 30,2020
    AMS Seeks Comments on Updates to NBFDS List of Bioengineered Foods
  • Jul 23,2020
    FDA Greenlights Qualified Health Claim for Cranberries, UTI Link
  • Jul 10,2020
    FDA To Use COVID-19 Risk Assessment System As It Restarts Domestic Inspections; Most Will Be Preannounced
  • Jul 9,2020
    NBFDS Final Guidances, FAQs Available on Validating Refining Process, Testing Methods
  • Jun 25,2020
    AMS Proposes To Add Three Substances to Organic Substances List
  • Jun 11,2020
    Stakeholder Groups Seek Changes to FDA’s Food Standards of Identity
  • Jun 10,2020
    Updated DOJ Guidance Provides Action Items for Corporate Personnel in Charge of Compliance Programs
  • May 28,2020
    FDA Offers Food Manufacturers, Vending Machine Operators Additional Temporary Labeling Flexibilities in Response to COVID-19
  • More

FDA Regulation & Enforcement

  • Oct 15, 2024
    Teva $450M Payment Resolves Kickback, False Claims Allegations Linked to Patient Co-Pays, Price Fixing
  • Oct 11, 2024
    OPDP Researchers To Examine Talk Show Drug Promotion; Move Ahead with Adherence and Preference Claims Study
  • Oct 9, 2024
    Vape Company Asks Court To Declare That FDA Civil Money Penalty Proceeding Violates Right to Jury Trial
  • Oct 8, 2024
    California To Standardize Quality, Safety Date Wording on Food Labels in 2026
  • Oct 3, 2024
    Stem Cell Company CEO Sentenced To Serve 36 Months in Prison for Distributing Unapproved Drug
  • Oct 2, 2024
    FDA Launches Office of Inspections and Investigations
  • Sep 27, 2024
    AI Company Reaches Agreement with Texas Over Marketing Claims
  • Sep 25, 2024
    DOJ Updates Tool for Evaluating Corporate Compliance Programs To Include Examination of How Firms Mitigate AI Risks
  • Sep 20, 2024
    Industry Concerned Draft Guidance on Responding to Misinformation Is Too Narrow and Raises First Amendment Issues
  • Sep 19, 2024
    Pharmacist Who Compounded Subpotent, Nonsterile Nuclear Drugs Pleads Guilty to Adulteration Charge
  • More

Medical Devices

  • Feb 15, 2023
    Orthotics Manufacturer Settles DOJ, North Carolina Fraudulent Medicaid Coding Allegations
  • Feb 15, 2023
    Device Associations Seek Improvements to FDA’s Voluntary Malfunction Summary Reporting Program
  • Feb 8, 2023
    Clinical Decision Support Software Firms Call for FDA To Withdraw Guidance To Encourage Development
  • Feb 2, 2023
    AdvaMed Calls for Consideration of Device Sterilization Needs As EPA Proposals on EtO Are Reviewed
  • Jan 26, 2023
    Study Examines Links Between 510(k) Devices With Class I Recalls and Predicates With Class I Recalls
  • Jan 25, 2023
    DePuy Synthes To Pay $9.75 Million To Resolve Allegations of Providing Free Devices to Surgeon
  • Jan 19, 2023
    FDA: Changes to Radiological Health Regulations Will Ease Industry’s Recordkeeping, Reporting Burden
  • Jan 12, 2023
    FDA, Health Canada Launch Pilot Program To Test Submissions of Premarket eSTARs to Both Agencies
  • Jan 5, 2023
    Jet Medical Resolves DOJ Allegations That It Marketed Device Without FDA Approval or Clearance
  • Dec 22, 2022
    Device Firm To Pay Over $12 Million To Resolve Claims Related to Alleged Misrepresentations to FDA
  • More

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