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Advertising and Promotion

  • Nov 3, 2025
    Industry Waits To See If FDA Makes Good on DTC Regulation Promise
  • Oct 6, 2025
    FDA’s SIUU Guidance: What Now?
  • Sep 12, 2025
    Questions Abound as FDA DTC Advertising Crackdown Begins
  • Aug 26, 2025
    MAHA Report May Force Companies To Reexamine DTC Promotions
  • Jul 21, 2025
    Continuing To Innovate During Regulatory Uncertainty
  • Jul 3, 2025
    DTC Ads in Political Crosshairs with No ‘Easy Fix’ in Sight
  • Jun 2, 2025
    The Promotional Review Committee Continues To Be the Gatekeeper in Omnichannel Marketing
  • Jun 1, 2025
    AI Is Coming to the FDA’s Review of Promotional Materials
  • Apr 22, 2025
    What To Do When the Regulators Go Away?
  • Mar 27, 2025
    OPDP Oversight and Enforcement Is Alive and Well in New Administration
  • More

Good Clinical Practice

  • Nov 15, 2018
    Don’t Overlook Institutional Conflicts of Interest
  • Oct 30, 2018
    Targeting Trial Recruitment Ads Can Be Tricky
  • May 2, 2018
    Investigator Brochures in Early Trials Found Wanting
  • May 2, 2018
    Audit Finds Non-Profits Fall Short on Trial Transparency Policies
  • Dec 8, 2017
    More Transparency Needed in Nutrition Research
  • Nov 27, 2017
    Practice of Excluding Prior Cancer Survivors from Clinical Trials Needs To Be Re-examined
  • Sep 15, 2017
    NIH Releases Tools To Aid Researchers in Implementing Recent Trial Policy Changes
  • Aug 23, 2017
    Number of FDA BIMO Inspections Drop Nearly 10 Percent in FY 2016
  • Aug 18, 2017
    IRBs Need To Rethink Payments to Research Subjects

Food Labeling

  • Aug 11, 2020
    It’s More than a New Graphic: How the New Nutrition Facts Panel Can Impact a Food’s Labeling, Marketing and Formulation
  • Sep 18, 2017
    CFSAN Wants Ideas on Reducing Regulatory Burdens
  • Sep 18, 2017
    FDA Allows First Qualified Health Claim To Prevent Food Allergy
  • Aug 15, 2017
    Rulemakings on Bioengineered Food, Revision of Facts Panel Are ’Inactive’

FDA Regulation & Enforcement

  • Jun 5, 2024
    Upcoming Listening Session on the FDA’s Advisory Committees Signals Possible Reforms
  • Aug 15, 2023
    Seven New Warning Letters on the Same Topic Should Tell You Something
  • Sep 8, 2022
    FDA, OECD Spearhead ‘Whole-of-Governments Approach’ To Combat Import of Illicit Products into U.S.
  • May 20, 2020
    Ready for Virtual FDA Inspections? Agency, Industry Face the Possibility as Pandemic Continues
  • Sep 10, 2018
    FDA Releases CDER Inspection Scheduling Policy, Pledges Faster Updates of Inspection Classifications
  • Sep 7, 2017
    CDER Review Staff To Work with ORA in New Team-Based Approach to Drug Facility Inspections
  • Aug 29, 2017
    FDA Seizure, Warning Letter Signal New Enforcement Initiative Targeting Stem Cell Therapies
  • Jul 5, 2017
    FDA To Delay Enforcement of DSCSA Drug Product Identifier, Verification Mandates

Medical Devices

  • Apr 9, 2025
    Expert: FDA Needs Capabilities To Help Mitigate Cybersecurity Risks Posed by Legacy Medical Devices
  • Feb 19, 2025
    Former Commissioner: FDA Policies May Limit Impact of AI Tools in Medicine, Despite Cures Act’s Intent
  • Jul 10, 2023
    Lab-Developed Tests: FDA Is Ready To Fight the Next Round
  • Nov 24, 2022
    AdvaMed Wants Administration To Ensure Delivery of Semiconductor Chips for Devices Through CHIPS Act
  • Nov 10, 2022
    Senate Policy Options Paper Raises Prospect of Additional Cybersecurity-Related Mandates for Devices
  • May 2, 2018
    Redesign, Recall, FDA Communication Address Persistent Issue of Infections Associated with Duodenoscopes
  • May 2, 2018
    FDA Safety Action Plan Promises Increased Focus on Total Product Life Cycle of Medical Devices
  • Sep 13, 2017
    CDRH Explores Streamlined Review of PMA Applications with Emphasis on Device Quality
  • Aug 1, 2017
    FDA Launches Program for Precertifying Software Companies with Records of Quality Design, Validation
  • Jul 25, 2017
    CDRH Announces Voluntary Pilot Program for Assessing Quality of Device Manufacturing

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