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Advertising & Promotion

  • Mar 26, 2018
    Physician Sentenced To Prison for Taking Kickbacks Disguised as Speaker Fees
  • Mar 22, 2018
    U.K. ASA Upholds Complaint Against Device Ad
  • Mar 22, 2018
    Arkansas Cities and Counties Join State in Lawsuit Against Opioid Makers
  • Mar 20, 2018
    NAD Refers Four Cases to FTC
  • Mar 19, 2018
    Five Doctors Indicted Over Speakers Program
  • Mar 19, 2018
    Settlements with Pharma Companies Remain Static
  • Mar 17, 2018
    OPDP Researchers Reveal Plans for 2018
  • Mar 17, 2018
    FDA Takes a Close Look at Warning Letters
  • Mar 17, 2018
    OPDP Researchers Plan Survey on HCP-directed Promotion
  • Mar 17, 2018
    More Entities File Opioid Marketing Lawsuits
  • More

Good Clinical Practice

  • Jul 21, 2018
    OHRP Issues Guidance on Revised Common Rule Burden-reducing Provisions
  • Jul 20, 2018
    ICH Guidance Examines Multiregional Trial Design
  • Jul 19, 2018
    FDA Issues Guidance on Use of EHR in Clinical Trials
  • Jul 18, 2018
    EMA Reports on First Year of Clinical Data Posting
  • Jul 17, 2018
    National Academies Panel Calls for Increased Return of Individual Research Results
  • Jul 17, 2018
    Public Citizen Denounces OHRP’s ‘Lax’ Enforcement
  • Jul 16, 2018
    VA-NCI Partner To Increase Trial Access
  • Jul 14, 2018
    Revised Common Rule’s ‘Burden-reducing’ Provisions Need Careful Consideration Before Adoption
  • Jul 14, 2018
    EU’s GDPR Causing More Problems for Researchers
  • Jul 14, 2018
    Alaska Gov. Signs ‘Right To Try’ Bill
  • More

U.S. Food Labeling

  • Sep 19,2013
    Groups Blast AMS Policy Change Reversing Position On Synthetics in National Organics List
  • Sep 16,2013
    Biotech Money Pouring into Campaign To Defeat GMO Labeling in Washington
  • Sep 16,2013
    House Member’s Op-Ed Lambasts FDA Over Menu Labeling Proposal
  • Sep 12,2013
    Federal Judge Shoots Down Injunction Halting Enforcement of COOL Labeling Disclosures
  • Sep 5,2013
    Ruling on Injunction in COOL Suit Expected Next Week
  • Sep 4,2013
    POM Asserts Free Speech Protections in Appealing FTC Order Barring Health Claims
  • Aug 28,2013
    CFSAN Cites Australian Cracker Company Over Unsupported Claims, Missing Disclosures
  • Aug 22,2013
    FDA Preps Study Gauging Consumer Reaction To Labeling Claims for Fortified Snack Foods
  • Aug 22,2013
    FDA Warns Medical Food Manufacturers To Avoid Drug-like Labeling Claims
  • Aug 8,2013
    FDA Issues Final Rule on ‘Gluten-free’ Labeling, Industry Has One Year to Comply With Changes
  • More

FDA Regulation & Enforcement

  • May 13, 2021
    FDA Undertakes Research on ‘Healthy’ Symbols as Prelude to Regulations
  • May 13, 2021
    Court: All but One Claim Brought Against ICD Manufacturer Are Preempted or Inadequately Pleaded
  • May 12, 2021
    Consumer Products Testing Firm Owner Pleads Guilty for Role in $46 Million Test Report Fraud Scheme
  • May 10, 2021
    Massachusetts Sues Marketing Company Over Opioid Campaigns
  • May 6, 2021
    Drug Maker To Pay $12.6 Million To Resolve Allegations That It Illegally Paid Copays Through Foundation
  • May 3, 2021
    Indivior Completes Settlement with States Over Suboxone Marketing
  • Apr 29, 2021
    Supreme Court: FTC Cannot Obtain Restitution, Disgorgement Without Prior Administrative Proceeding
  • Apr 29, 2021
    FASTER Act Is Now Law; Adds Sesame to List of Major Allergens for Labeling
  • Apr 26, 2021
    OPDP Mandates eCTD Submission of Form FDA 2253 Starting in June
  • Apr 21, 2021
    Guidance Heralds FDA’s Expanding Use of Remote Interactive Evaluations in Place of Inspections
  • More

Medical Devices

  • May 31, 2016
    District Court Drops ‘Off-label’ Claims But Continues False Claims Act Case Against Medtronic
  • May 26, 2016
    Court: Plaintiffs Failed To Allege Parallel Claims Against Device Maker That Survive Preemption
  • May 25, 2016
    FDA Final Order Reclassifies External Cardiac Compressors, CPR Aids, Revises Regulations
  • May 25, 2016
    Washington, California Sue J&J, Ethicon Over Surgical Mesh Misrepresentations
  • May 17, 2016
    Expanded CDRH Guidance on Postmarket Surveillance Offers Suggestions for Proposed Plans, Reports
  • May 11, 2016
    Senate Report: Physician-Owned Distributorships Harder To Identify, Spreading to More Practice Areas
  • May 11, 2016
    FDA Offers Draft Recommendations for Devices Produced Through Additive Manufacturing
  • May 4, 2016
    AdvaMed Calls for Modifications to FDA’s Draft Guidance on Postmarket Device Cybersecurity
  • Apr 28, 2016
    Court: Length of Need for Purchased Device Is Immaterial to Reimbursement Decision
  • Apr 27, 2016
    FDA Creates Combination Products Policy Council To Resolve Disputes, Coordinate Policies
  • More

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