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Advertising & Promotion

  • Jul 24, 2019
    CBD Maker Receives Warning Letter Over Unsubstantiated Marketing Claims
  • Jul 24, 2019
    NAD Recommends Drop Maker Discontinue Challenged Claims
  • Jul 19, 2019
    OPDP Researchers Move Ahead with Study on Physician Perception of Professional Pieces
  • Jul 18, 2019
    Court Dismisses FCA Case Against Analyzer Maker Over Marketing
  • Jul 18, 2019
    Senators Renew Effort To Enact Legislation Requiring Pricing Info in DTC TV Drug Ads
  • Jul 17, 2019
    Health Canada Opens Consultation on Distinction Between Promotional and Non-Promotional Items
  • Jul 14, 2019
    Federal Court Rejects Corrective Advertising Request in Drug Compounding Case
  • Jul 13, 2019
    Reckitt Benckiser Group To Pay $1.4 Billion To Resolve Federal Investigation of Opioid Treatment Marketing
  • Jul 9, 2019
    Court Stays Rule Requiring Price Disclosures in DTC TV Ads
  • Jul 4, 2019
    Dietary Supplement Maker Discontinues Claims After NAD Review
  • More

Good Clinical Practice

  • Aug 29, 2019
    CDRH Researchers Find Consent Forms May Impede Subject Understanding
  • Aug 28, 2019
    FDA Offers Investigator Training in November
  • Aug 27, 2019
    FDA Encourages Inclusion of Male Subjects in Breast Cancer Clinical Trials
  • Aug 26, 2019
    Push for Sanctions Made for Failure To Report Trial Results in the UK
  • Aug 23, 2019
    FDA Releases Revised Draft Guidance on Trial Considerations for Gastroparesis Drugs
  • Aug 23, 2019
    One CDRH Regulatory Science Focus Is To Develop Ways To Improve Trial Design
  • Aug 23, 2019
    FDA Issues Draft Recommendations on Fabry Disease Trial Design Features
  • Aug 21, 2019
    FDA Updates COA Compendium
  • Aug 21, 2019
    ACRP Partners with VirTrial for Training
  • Aug 19, 2019
    District Court Allows Trial Injury Case To Continue
  • More

U.S. Food Labeling

  • Jun 14,2017
    FDA Announces Intention To Extend Compliance Dates for Rules on Nutrition Facts Label, Serving Sizes
  • Jun 12,2017
    Public Interest Groups Sue FDA for Delaying Compliance Date for Menu Labeling Mandates
  • Jun 7,2017
    Court Refuses To Dismiss Suit Over Company’s Listing of ‘Evaporated Cane Juice’ as Ingredient
  • May 31,2017
    FDA Sampling Finds High Level of Compliance with Gluten-free Labeling Standard
  • May 25,2017
    Sargento Being Sued Over Labeling Its Cheeses As ‘Natural’
  • May 18,2017
    FDA Withdraws Draft Guidance on Use of Vegetable, Fruit Juice as Color Additive
  • May 11,2017
    New Rule for Livestock and Poultry Using Organic Seal Postponed
  • May 9,2017
    Gottlieb Confirmed by Senate as New FDA Commissioner
  • May 2,2017
    FDA Delays Menu Labeling Compliance Date to 2018
  • Apr 27,2017
    Appeals Court Remands Gerber Labeling Case to District Court
  • More

FDA Regulation & Enforcement

  • Mar 23, 2023
    Second Cell Cultured Food Is Given Safety Greenlight
  • Mar 23, 2023
    FDA Allows Cocoa Flavanol Qualified Health Claim
  • Mar 17, 2023
    ABPI Suspends Novo Nordisk Over Sponsored Course Promoted on LinkedIn
  • Mar 16, 2023
    Proposed New FDA Enforcement Authorities for FY 2024 Include Expansions of Remote Regulatory Assessments
  • Mar 16, 2023
    Interviews with Health Care Influencers Find Resistance to Company Messaging
  • Mar 16, 2023
    Manufacturer To Pay $10 Million, CEO Indicted in Connection With Marketing of ‘Dummy’ Device
  • Mar 10, 2023
    USDA Proposes To Regulate ‘Made in USA’ Label Claim To Better Align With Consumer Perceptions
  • Mar 7, 2023
    Permanent Injunctions Entered Against Three Distributors Over Marketing Claims
  • Mar 7, 2023
    DOJ To Require Compliance-Related Criteria in Compensation Programs as Part of Criminal Resolutions
  • Mar 2, 2023
    Draft Guidance Allows Use of ‘Milk,’ Recommends Nutrition Information on Plant-Based Product Labeling
  • More

Medical Devices

  • Feb 3, 2020
    FDA Public Workshop To Explore Challenges Facing Developers of Extended Reality Medical Devices
  • Jan 31, 2020
    House Bill Would Extend FDA’s Administrative Destruction Authority to Devices, Combination Products
  • Jan 29, 2020
    Responding to Coronavirus Outbreak, FDA Offers Emergency Authorization Pathway for New Diagnostics
  • Jan 24, 2020
    GE Healthcare Product Vulnerabilities Prompt Ninth FDA Safety Communication on Device Cybersecurity
  • Jan 22, 2020
    FDA Issues Classification Decisions for Radiological Triage Software, Medical Image Analyzers
  • Jan 17, 2020
    Sleep Apnea DME Manufacturer To Pay More than $37.5 Million To Resolve Kickback Allegations
  • Jan 15, 2020
    FDA Exempts Powered Wheeled Stretchers from 510(k) Mandates in Response to Stryker Petition
  • Jan 6, 2020
    FDA Amends Classification Regulations for Class I, Class II Devices Exempted from 510(k) Requirements
  • Jan 2, 2020
    FDA Outlines How Sponsors of Combination Products Should Seek Feedback from Agency Staff
  • Dec 23, 2019
    Medical Device Excise Tax Is Repealed
  • More

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