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Advertising & Promotion

  • Jul 14, 2021
    Physician Sentenced to More than 17 Years in Prison for Kickback, Controlled Substances Violations
  • Jul 11, 2021
    Two Bills Introduced in Senate Call for Price Disclosures in Direct-to-Consumer Ads
  • Jul 8, 2021
    Avanos Medical $22 Million Settlement Resolves Charge of Fraudulently Misbranding Surgical Gowns
  • Jul 2, 2021
    J&J Reaches Settlement with New York Over Opioids
  • Jun 30, 2021
    HHS OIG: Device Maker’s Discount Program for Hospitals Would Not Raise Health Care Fraud Concerns
  • Jun 26, 2021
    OPDP Continues Study of Unapproved Use Data
  • Jun 21, 2021
    GAO Finds DTC Ads May Be Factor in Medicare Costs
  • Jun 13, 2021
    OPDP Researchers To Examine Accelerated Approval Disclosures on DTC Websites
  • Jun 10, 2021
    Study Finds Even Meals May Influence Insulin Prescriptions
  • Jun 2, 2021
    Medicrea Settlement Continues Emerging DOJ Trend of Including Open Payments Violation Allegations in Settlements
  • More

Good Clinical Practice

  • Sep 3, 2021
    FDA: Re-review of Trial Data Reviewed Remotely Should Be Based on an Assessment of Risk
  • Aug 29, 2021
    Senate Bill Looks To Aid Diversity in Trials
  • Aug 24, 2021
    Trial Transparency Still a Problem for Smaller Companies
  • Aug 13, 2021
    Cardiology Group Presses for More Women in Trials
  • Aug 5, 2021
    FDA Debars CRC for Five Years for Falsifying Case Report Forms
  • Jul 30, 2021
    FDA: Inclusion of Pregnant and Breastfeeding Women in Clinical Trials Is Needed
  • Jul 27, 2021
    SACHRP Makes Recommendations To Help Research Community Reassess Principle of Justice
  • Jul 20, 2021
    UK Starts Combined Regulatory-Ethics Review for Trials
  • Jul 15, 2021
    Study Finds That Sex Bias Persists in Trials
  • Jul 2, 2021
    FDA Encourages Inclusion of Subjects with Incurable Cancers in Oncology Clinical Trials
  • More

U.S. Food Labeling

  • Feb 27,2020
    FTC Files Action Against Two Firms Alleging False Product Claims
  • Feb 12,2020
    Class Action Against Coca-Cola Co. Challenges ‘Just a Tad Sweet’ Claim
  • Feb 12,2020
    Small Firm Nutrition Facts Compliance Guide Now Available
  • Jan 30,2020
    New Biotech Regulatory Website Now Up and Running
  • Jan 30,2020
    Senators Press FDA To Move Against ‘Misuse' of Dairy Terms on Nondairy Product Labeling
  • Jan 30,2020
    AMS Extends Comment Deadline on Draft Instructions for Validating Methods To Detect Genetic Material for Labeling
  • Jan 16,2020
    FDA Finalizes New Food Labeling Serving Size Guidance
  • Dec 26,2019
    Court Grants Injunction Against Arkansas Meat-labeling Law
  • Dec 19,2019
    Draft Instructions Posted for Validation of Methods To Detect Genetic Material for Labeling Under NBFDS
  • Dec 12,2019
    Dr. Stephen Hahn Confirmed as New FDA Commissioner
  • More

FDA Regulation & Enforcement

  • Aug 13, 2024
    Court: Claims Challenging Marketing of Tylenol Rapid Release Gelcaps Are Expressly Preempted
  • Aug 12, 2024
    OPDP Plans To Survey HCPs About Bad Ad Program and Other Issues
  • Aug 9, 2024
    FSANZ Consumer Survey Finds More Trust in Back-of-Package Labeling
  • Aug 7, 2024
    DOJ Expands Whistleblower Opportunities in Corporate Criminal Cases Through Awards Pilot Program
  • Aug 2, 2024
    OPDP Issues Two Untitled Letters
  • Jul 31, 2024
    District Court: State Law Tort Claims Involving Class II De Novo Device Are Expressly Preempted
  • Jul 26, 2024
    OPDP Research Finds Disease Awareness Ads Could Confuse Consumers on Drug Risks and Benefits
  • Jul 24, 2024
    HHS OIG: Lack of Data Prevents Favorable Assessment of Fraud Risk Posed by Fertility Treatment Help
  • Jul 19, 2024
    Group Offers ‘Seed Oil Free Certified’ Seal
  • Jul 17, 2024
    Compounder Pleads Guilty, Former Sales Exec Indicted in Connection With Vet Drug Kickback Scheme
  • More

Medical Devices

  • Oct 6, 2022
    FDA Sets FY 2023 Device User Fee Rates Following Reauthorization in Stopgap Government Funding Bill
  • Sep 29, 2022
    Final Clinical Decision Support Software Guidance Expands Info on Functions Not Regulated as Devices
  • Sep 22, 2022
    DOJ Toughens Stance on Companies With Histories of Misconduct, Seeks To Encourage Self-Disclosure
  • Sep 21, 2022
    Final 510(k) Template Guidance Moves FDA Toward October 2023 Electronic Submission Mandate
  • Sep 15, 2022
    FDA Offers Draft Recommendations on Computer Software Assurance for Manufacturing, Quality Systems
  • Sep 7, 2022
    Respironics Settles Allegations That It Gave Prescribing Data to DME Suppliers To Induce Purchases
  • Aug 31, 2022
    N.C. Device Maker Agrees To Pay Over $785,000 To Resolve Allegations of False Medicare Coding
  • Aug 29, 2022
    Court Allows Federal FCA Case Against Abbott to Proceed
  • Aug 24, 2022
    Optical Lens Maker To Pay $22 Million To Resolve False Claims Liability Tied to Alleged Kickbacks
  • Aug 18, 2022
    EPA Plans To Propose Rule on EtO Emissions That Could Impact Sterilization of Medical Devices
  • More

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