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Breadcrumb

  • News
  • FDA Intelligence

Advertising and Promotion

  • Jan 15, 2021
    Latest FDA Intended Use Proposal Lacks Clarity, Falls Short on Legal Grounds, Comments Assert
  • Dec 30, 2020
    Untitled Letter Provides Reminder of Basic Promotion Requirements
  • Dec 30, 2020
    OPDP Issues Few Enforcement Letters in 2020 But They Have High Impact
  • Dec 7, 2020
    Speaker Program Reexamination Needed After OIG Alert
  • Nov 23, 2020
    Administration’s Most Favored Nation Pricing Plan Could Affect Industry Profitability
  • Oct 7, 2020
    Tom Abrams’ Legacy at OPDP
  • Sep 11, 2020
    New Normal for Ad Promo Is Likely the Old Normal
  • Sep 9, 2020
    Limitations of Promotional Claims on Facial Masks Marketed under Emergency Use Authorizations
  • Aug 18, 2020
    FDA’s 'Intended Use' Saga
  • Jul 27, 2020
    Bad Ad Program At 10
  • 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

  • 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

  • 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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