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Advertising & Promotion

  • Nov 30, 2017
    District Court Rejects $7.2 Million Aegerion Plea Agreement, Orders Case To Proceed to Trial
  • Nov 22, 2017
    OPDP Sends Warning Letter to Two Companies Over Zolpimist Web Page and Exhibit Panels
  • Nov 22, 2017
    FTC Settles False Advertising Charges Against Florida Supplement Sellers
  • Nov 17, 2017
    Two Congressional Bills Target DTC Ads; McCaskill Looks To End Ad Deduction
  • Nov 17, 2017
    FTC Settles Deceptive Ad Case with Online Marketers
  • Nov 16, 2017
    Olympus Reaches $1.075 Million Settlement with California
  • Nov 11, 2017
    Cuyahoga County, Ohio, Files Opioid Lawsuit
  • Nov 10, 2017
    Kentucky Sues Endo Over Opana ER Marketing
  • Nov 9, 2017
    28 Wisconsin Counties Sue Opioid Manufacturers
  • Nov 9, 2017
    Michigan Bill Would Require Cost Reporting Including Marketing Costs for High Price Drugs
  • More

Good Clinical Practice

  • Mar 27, 2018
    Lupus Researchers Call for More Reliable, Smaller, Shorter Trials
  • Mar 27, 2018
    Study Examines Placebo Effect
  • Mar 26, 2018
    Tufts Study Finds Site Start-up Taking Longer
  • Mar 26, 2018
    Research Misconduct Reports Need Improvement; JAMA Viewpoint Proposes Checklist
  • Mar 26, 2018
    Proposed FAQs Consider Secondary Use Questions
  • Mar 23, 2018
    New EU Data Protection Reg Causes Research Concerns
  • Mar 22, 2018
    House Passes Right to Try Bill; Reconciliation Next
  • Mar 22, 2018
    Pa. Senate Revives Bill on Cancer Trial Reimbursement
  • Mar 22, 2018
    Researcher Settles False Claims Act Case
  • Mar 21, 2018
    Australia’s TGA Offers Trial Handbook
  • More

U.S. Food Labeling

  • Dec 8,2012
    California Voters Say ‘No’ to Proposition 37: Proponents Concede Defeat Day After Election
  • Dec 6,2012
    Survey: Markets, Convenience Stores Well Equipped For Inclusion in FDA Menu Labeling Requirements
  • Nov 9,2012
    HHS Inspector General: Structure/Function Claims in Supplements Coming Up Short
  • Nov 5,2012
    Fake News Operator To Settle FTC Charges for More than $2 Million
  • Nov 4,2012
    Sales by Organic Growers Top $3.5 Billion
  • Nov 1,2012
    OIG Also Finds That Supplement Manufacturers May Be Hard To Find in Emergencies
  • Nov 1,2012
    OIG: Many Supplement Claims Not in Compliance
  • Oct 1,2012
    FDA: Dietary Supplements Promoted as Drugs To Treat Concussions
  • Sep 30,2012
    McDonald's To Display Calories on Menu Boards Nationwide Ahead of FDA's Final Regulation
  • Sep 30,2012
    Kellogg Agrees To Modify Froot Loops Website
  • More

FDA Regulation & Enforcement

  • Dec 16, 2020
    OPDP Researchers Move Ahead with Endorsement Studies, Report on Completed Research
  • Dec 10, 2020
    District Court: State Law Tort Claims Related to PMA Cardiac Device Are Not Preempted by Federal Law
  • Dec 10, 2020
    Court Refuses To Enjoin Oklahoma Plant-Based Meat Labeling Law; Plaintiffs Appeal
  • Dec 9, 2020
    Regeneron Must Face Anti-Kickback Statute Allegations Involving Foundation Co-pay Fund Donations
  • Dec 8, 2020
    Seeking Permanent Injunction, DOJ Cites Consultant Emails to Undercover FDA Representative
  • Dec 4, 2020
    OPDP Issues Second Untitled Letter of 2020
  • Dec 3, 2020
    PhRMA, Other Groups Sue HHS, FDA To Block Rule Allowing Importation of Rx Drugs from Canada
  • Dec 2, 2020
    Companies Settle FCA Case Over Improper Promotion of Drug-Device Combo Product for Pediatric Use
  • Nov 24, 2020
    House Passes Bill To Add Sesame to Regulated List of Allergens
  • Nov 24, 2020
    HHS Shuts Down FDA’s Unapproved Drugs Initiative, Saying It Led to Price Increases, Product Shortages
  • More

Medical Devices

  • Aug 17, 2015
    Compliance Date for Some Unique Device Identifier Data Submissions Extended to Oct. 24
  • Aug 13, 2015
    Electronic MDR Submission Requirements for Device Manufacturers, Importers Go Into Effect
  • Aug 6, 2015
    FDA Warns of Symbiq Infusion System’s ‘Cybersecurity Vulnerabilities’
  • Aug 6, 2015
    FDA Plans December 2015 Beta Release of Platform for Development of NGS Tests
  • Aug 6, 2015
    Device User Fee Rates To Increase by More Than 4 Percent in FY 2016
  • Aug 4, 2015
    Revised 510(k) Refuse-To-Accept Policy Guidance Document Issued; Changes Effective October 1
  • Jul 30, 2015
    NuVasive Settlement Resolves DOJ Investigation Into ‘Possible False’ Medicare, Medicaid Claims
  • Jul 23, 2015
    CDRH Plans September Public Workshop, Asks for Comments on Device Patient Labeling
  • Jul 14, 2015
    Draft Guidance Presents Suggestions for 510(k)s for Magnetic Resonance Diagnostic Devices
  • Jul 9, 2015
    FDA Proposes Labeling, Safety Testing Guidelines for Devices Containing Heparin
  • More

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