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Advertising & Promotion

  • Feb 4, 2022
    More States, Tribes Settle Lawsuits Over Opioid Marketing
  • Jan 28, 2022
    OPDP Issues First Untitled Letter of 2022
  • Jan 21, 2022
    Bill To Remove DTC Prescription Drug Advertising Deduction Introduced in US House
  • Jan 14, 2022
    OPDP Reminds Companies in Untitled Letter That Complete Promotions Must Be Submitted
  • Jan 7, 2022
    OPDP Adds New Division
  • Dec 31, 2021
    Oregon Sets Temporary Rules for Sales Rep Licensing
  • Dec 24, 2021
    District Court Allows Qui Tam Suit Over Marketing Claims and Speaker Programs To Continue
  • Dec 17, 2021
    FDA Plans To Release Final Rule on DTC Ads in September
  • Dec 14, 2021
    House Committee Report Critiques Pharma Business, Pricing Practices
  • Dec 9, 2021
    Allergan Settles with New York over Opioid Marketing
  • More

Good Clinical Practice

  • Apr 13, 2022
    Bills Requiring Drug Trial Cost Reporting Introduced
  • Apr 2, 2022
    FDA Issues Three Final Guidances To Aid Cancer Trials
  • Mar 25, 2022
    SACHRP: Research Enterprise Needs To Do More To Protect Non-subjects
  • Mar 18, 2022
    OHRP Issues First Determination Letters Since 2020; Investigator Receives FDA Warning Letter
  • Mar 17, 2022
    OIG: Device Firm’s Cost-Sharing Subsidies for Clinical Study Would Pose Only Minimal Risk of Fraud
  • Mar 14, 2022
    FDA Permanently Debars Two Clinical Trial Site Staff Members
  • Mar 7, 2022
    FDA BIMO Inspections Down 17% in FY 2021
  • Feb 25, 2022
    FDA Provides Guidance on Screening and Exit Interviews in Clinical Trials
  • Feb 20, 2022
    FDA Warning Letter Alleges Informed Consent, IRB Violations
  • Feb 15, 2022
    Proposed Senate HELP Committee Pandemic Bill Includes Provisions To Modernize Trials
  • More

U.S. Food Labeling

  • Jan 21,2021
    FTC, FDA Move Against Dozens of Supplement Firms Making False COVID-19 Claims
  • Jan 7,2021
    ANPR Issued on USDA’s Oversight of Genetically Engineered Animals
  • Jan 7,2021
    Petition Seeks Dietary Fiber Consideration for Gum Acacia
  • Jan 7,2021
    FDA Sets New Food Labeling Uniform Compliance Date
  • Jan 7,2021
    Supplement Firm Owner Pleads Guilty to Drug Distribution
  • Jan 7,2021
    FDA Warns Retailer About Undeclared Allergens
  • Dec 23,2020
    FDA Finalizes Labeling Guidance on Alternate Name for Potassium Chloride
  • Dec 10,2020
    Court Refuses To Enjoin Oklahoma Plant-Based Meat Labeling Law; Plaintiffs Appeal
  • Nov 24,2020
    House Passes Bill To Add Sesame to Regulated List of Allergens
  • Nov 12,2020
    FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen
  • More

FDA Regulation & Enforcement

  • 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
  • Jul 13, 2024
    District Court Finds ‘Manufactured in the USA’ Label False
  • Jul 13, 2024
    FDA To Exercise Enforcement Discretion for ‘Tailored’ Responses to Internet Misinformation
  • More

Medical Devices

  • Apr 5, 2023
    FDA: Draft Guidance Will Spur Development of AI/Machine-Learning Devices, Reduce Sponsor Burden
  • Mar 29, 2023
    For Transition From COVID-19 EUAs, Enforcement Policies, FDA Urges Sponsors To Prep New Submissions
  • Mar 23, 2023
    COVID-19-Related EUAs To Remain In Effect Following Expiration of Public Health Emergency
  • Mar 16, 2023
    Manufacturer To Pay $10 Million, CEO Indicted in Connection With Marketing of ‘Dummy’ Device
  • Mar 8, 2023
    Device Cybersecurity Mandates Enacted by Congress Set Premarket Submission, Monitoring Requirements
  • Mar 1, 2023
    Jury Returns Kickback, False Claims Verdict for Over $43 Million Against Ophthalmic Device Distributor
  • Feb 22, 2023
    Citing Preemption, Court Dismisses Claims That Surgical Clip Maker Failed To Report Adverse Events
  • Feb 22, 2023
    CDRH Issues Warning Letter Over Off-label Promotion
  • 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
  • More

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