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Advertising & Promotion

  • Dec 24, 2019
    District Court Allows False Ad Case to Continue
  • Dec 23, 2019
    Payments, Meals and Travel Tied To Physician Prescribing Rates
  • Dec 21, 2019
    Company Settles TGA Concerns Over Opioid Marketing to Health Professionals
  • Dec 20, 2019
    Senate Bills Introduced Dealing with DTC Ads
  • Dec 19, 2019
    Survey Assesses Oncologists’ View of Company Interaction
  • Dec 19, 2019
    Senators Ask Purdue To Reevaluate Its Incentive Program; Scrap CEO Bonus
  • Dec 13, 2019
    House Drug Cost Bill Includes Mandate for Pricing in Television DTC Drug Ads
  • Dec 12, 2019
    Dr. Stephen Hahn Confirmed as New FDA Commissioner
  • Dec 11, 2019
    OPDP Issues Third Warning Letter for 2019
  • Dec 10, 2019
    Senators Call for HHS OIG Investigation of Patient Assistance Programs
  • More

Good Clinical Practice

  • Dec 12, 2019
    Dr. Stephen Hahn Confirmed as New FDA Commissioner
  • Dec 9, 2019
    ASH Joins LLS Trial Support Center
  • Dec 9, 2019
    FDA Draft Guidance Details Trial Considerations for Short-term Hemorrhoid Treatment Drugs
  • Dec 6, 2019
    FDA Issues Draft Guidance on IC/BPS Trial Design
  • Dec 4, 2019
    FDA-MHRA Co-host GCP Symposium
  • Dec 2, 2019
    FDA Final Guidance on Adaptive Trial Designs Is Little Changed from 2018 Draft Guidance
  • Dec 2, 2019
    Pakistan Releases First Trial Conduct Guidelines
  • Dec 2, 2019
    Australia Opens $100 Million Grant Program To Aid Rural Clinical Trials
  • Nov 27, 2019
    Owner of Trial Site Convicted of Fraud
  • Nov 27, 2019
    Group Calls for Sex and Gender Analyses in Australian Trials
  • More

U.S. Food Labeling

  • Apr 5,2018
    AMS Extends Approval for 17 Substances Currently on ‘Organic’ Substances National List
  • Mar 29,2018
    Distributor of Supplements Containing Undisclosed APIs Shuttered Under Terms of FDA Consent Decree
  • Mar 29,2018
    Stakeholder Group Says Funding Bill Instructs FDA To Enforce ‘Milk’ Labeling
  • Mar 22,2018
    FDA Will Consider Cranberry Juice, UTI Link as ‘Qualified’ Health Claim
  • Mar 20,2018
    Enforcement Briefs: Warning Letters
  • Mar 14,2018
    As Expected, USDA Withdraws OLPP 2017 Final Rule
  • Mar 7,2018
    Agencies Are Seeking Input on Updated Dietary Guidelines
  • Mar 5,2018
    New Guidances Posted on Revised Nutrition Facts Label
  • Mar 1,2018
    Stakeholders Ask Agencies To Update Definitions of 'Beef,' 'Rice'
  • Feb 16,2018
    FSIS Wants To Overhaul Egg Products Labeling Practices
  • More

FDA Regulation & Enforcement

  • Sep 30, 2023
    Citizen Petition Requests That Gluten Be Declared a Major Food Allergen
  • Sep 27, 2023
    FDA Drafts Guidelines for Use of Alternative Oversight Tools in Connection With Drug Applications
  • Sep 25, 2023
    Bill To Study ‘Climate-Friendly’ Certification and Labeling Introduced in US House
  • Sep 20, 2023
    Citing Implied Preemption, First Circuit Affirms Dismissal of Complaint Targeting Lactaid Label Claims
  • Sep 15, 2023
    GAO Finds Few Studies, Conflicting Opinions on DTC Device Ads
  • Sep 14, 2023
    DOJ Counters Device Maker’s Argument That False Claims Act Qui Tam Suits Violate U.S. Constitution
  • Sep 8, 2023
    French Study Finds Two FOL Statements Can Be Independently Perceived and Understood
  • Sep 7, 2023
    DOJ Says Firm’s Regenerative Veterinary Products Are Unapproved Drugs, Asks Court for Injunction
  • Sep 1, 2023
    OPDP Issues Untitled Letter About Sponsored Social Media Post
  • Aug 30, 2023
    Physician Pleads Guilty to Charges Related to Use of Smuggled, Unapproved Cosmetic Drugs
  • More

Medical Devices

  • Jan 20, 2021
    FDA Announces Plan for Regulating Software Devices Using Artificial Intelligence, Machine Learning
  • Jan 14, 2021
    HHS Permanently Exempts Seven COVID-19-Related Medical Devices from FDA’s 510(k) Requirements
  • Jan 7, 2021
    Congress Expands FDA’s Administrative Destruction Authority To Include Imported Medical Devices
  • Jan 7, 2021
    FDA Finalizes Guidance for Program Offering Expedited Review for Devices with Safer Technologies
  • Dec 30, 2020
    FDA Finalizes Labeling Guidance, Updates Safety Communication on Laparoscopic Power Morcellators
  • Dec 24, 2020
    Device Company CEO Charged with Securities Fraud for Falsely Claiming Development of COVID-19 Test
  • Dec 16, 2020
    Catheter Maker Issues Urgent Recall of Device Following Reports of 14 Deaths, Hundreds of Injuries
  • Dec 10, 2020
    District Court: State Law Tort Claims Related to PMA Cardiac Device Are Not Preempted by Federal Law
  • Dec 2, 2020
    CISA: Cybersecurity Vulnerability in BD Alaris Infusion Pumps Could Affect Wireless Capability
  • Dec 2, 2020
    GAO Finds Persistent COVID-19 Supply Shortages, Inconsistent Testing Guidance from Federal Agencies
  • More

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