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Advertising & Promotion

  • Sep 14, 2021
    OPDP Researchers Continue Secondary and Biosimilar Disclosure Studies, Detail Other Research Results
  • Sep 8, 2021
    Federal Enforcement Eying Open Payments Compliance
  • Aug 27, 2021
    PhRMA Revises Code Guidelines on Speaker Programs
  • Aug 20, 2021
    OPDP Issues Untitled Letter Over Alleged Lack of Risk Information in Sponsored Links
  • Aug 13, 2021
    OPDP Researchers Announce Completion of HCP Survey
  • Aug 10, 2021
    Oregon To Require Drug Sales Rep. Licensing
  • Aug 2, 2021
    After Six Years, FDA Finalizes Rule on the Evidence Used To Determine the Intended Uses of Devices
  • Jul 30, 2021
    OPDP Adds Three Topic-Based Questions to FAQs
  • Jul 23, 2021
    State AGs Reach Settlement with J&J, Distributors
  • Jul 16, 2021
    OPDP Issues Second Untitled Letter of 2021
  • More

Good Clinical Practice

  • Nov 5, 2021
    BMJ Investigation Alleges Problems at Three Clinical Sites in Pivotal COVID-19 Vaccine Trial
  • Oct 29, 2021
    BIMO Inspection 483s Increase by a Third in FY 2021
  • Oct 28, 2021
    FDA Warning Letter Alleges Investigator Failed To Follow Investigational Plan for Clinical Trial
  • Oct 28, 2021
    HHS OIG: Medicare Co-Pay Subsidies for Alzheimer’s Disease Study Subjects Would Not Trigger Sanctions
  • Oct 20, 2021
    Two Sponsor-Investigators Issued Warning Letters for Failing To Submit INDs
  • Oct 14, 2021
    FDA Issues Warning Letter to Second Sponsor for Failing to Submit INDs
  • Oct 1, 2021
    FDA Issues Draft Guidance on Investigator Responsibilities Regarding Safety Reporting
  • Sep 29, 2021
    FDA Rejects Study Data from Two Labs in India
  • Sep 17, 2021
    FDA Issues Sponsor-Investigator Notice for Not Posting Results
  • Sep 10, 2021
    Trial Sponsor Receives Warning Letter over Investigational Product FDA Considers Drug, Not Food
  • More

U.S. Food Labeling

  • May 13,2020
    AMS Extends Sunset Date of Various Substances on Organic Substances List
  • Apr 30,2020
    FDA Extends Comment Period on Principles for Food Standards Modernization
  • Apr 16,2020
    FSIS Says Product of USA Labeling May Be ‘Confusing,’ Will Initiate Rulemaking
  • Apr 2,2020
    FDA, FSIS Offer Labeling Flexibilities in Response to COVID-19
  • Mar 18,2020
    FSIS Reaffirms Consistent Use of ‘Healthy’ Claims as Allowed by FDA
  • Mar 16,2020
    FDA Initiates Educational Campaigns on Nutrition Labeling, GMO Food
  • Mar 16,2020
    FDA Sends CBD Report to Congress That Fails To Give Specifics on Moving Forward
  • Mar 12,2020
    Interest Group, Others Sue USDA Over ‘Organic’ Certification for Hydroponics
  • Mar 7,2020
    Labeling Violations Cited in Warning Letter
  • Mar 7,2020
    Survey Results Show Consumer Confusion About Plant-based Meat Products
  • More

FDA Regulation & Enforcement

  • Sep 15, 2024
    AbbVie Receives Untitled Letter Over Ubrelvy TV Ad
  • Sep 11, 2024
    Device Maker To Pay $700K To Resolve Allegations of Encouraging Use of Incorrect Billing Codes
  • Sep 10, 2024
    FSIS Updates Substantiation Guidance for Animal-Raising and Environmental Label Claims
  • Aug 28, 2024
    DOJ Adds Conspiracy, Fraud Charges Against Biolab Operator Who Allegedly Sold Illegal COVID-19 Tests
  • Aug 28, 2024
    CEO of Stem Cell Product Manufacturing Firm Pleads Guilty to Felony Distribution of Unapproved Drug
  • Aug 27, 2024
    FDA Promises FOPL NPRM in October, Final Rule on ‘Healthy’ Definition in September
  • Aug 23, 2024
    FTC Approves Final Rule on Product Reviews and Testimonials
  • Aug 23, 2024
    FDA Moves to Phase II of Its Sodium Reduction Program
  • Aug 21, 2024
    Pharma Distributor Urges Supreme Court Not To Hear Case Seeking Interpretation of Anti-Kickback Statute
  • Aug 16, 2024
    Appeals Court Rejects Challenge to USDA’s Decision on Poultry Labeling
  • More

Medical Devices

  • Dec 15, 2022
    FDA Guidance on Inspection Refusals That Can Deem a Drug Adulterated Is Updated To Include Devices
  • Dec 14, 2022
    FDA Seeks To Boost Device Manufacturer Participation in Voluntary Malfunction Summary Reporting
  • Dec 8, 2022
    CDRH Offers More Recommendations on Presenting Human Factors Info in Device Marketing Submissions
  • Dec 1, 2022
    Plaintiffs’ Claims Based on Alleged Misuse of Alternative Summary Reporting Survive Motion To Dismiss
  • Nov 17, 2022
    Court Dismisses Patient’s 17 State Law Claims Against Maker of Essure Birth Control Device
  • Nov 3, 2022
    Cybersecurity, De Novo Electronic Template, Transitioning From COVID Policies Top Guidance Priorities
  • Oct 26, 2022
    FDA Proposes Expansion of Breakthrough Device Designation To Include Products Advancing Health Equity
  • Oct 19, 2022
    FDA Warns Device Firms That UDI Enforcement Discretion for Legacy Identifiers Ends in September 2023
  • Oct 13, 2022
    FDA Proposes Rule for Administrative Destruction of Some Devices Refused Admission at U.S. Border
  • Oct 12, 2022
    With Enactment of MDUFA V, CDRH Launches Pilot Program To Help Speed Quality Devices to Market
  • More

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