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Advertising & Promotion

  • Feb 6, 2019
    Delaware Court Allows State Opioid Marketing Lawsuit to Continue
  • Feb 5, 2019
    Bill Requiring Reporting of Marketing Costs for Expensive Drugs Introduced in Minnesota
  • Feb 4, 2019
    Federal Appeals Court Reverses Summary Judgment Favoring Company in Off-label Marketing Case
  • Feb 1, 2019
    Amended Complaint Provides More Detail for Massachusetts Lawsuit Against Purdue Pharma
  • Jan 31, 2019
    Small Study Finds Cost Mitigation Disclosures Lessen Price Shock in DTC Drug Ads
  • Jan 29, 2019
    NAD Upholds Some Claims for Abbott Milk Fortifier, Recommends Changes for Others
  • Jan 24, 2019
    Survey Finds Most Physicians Would Not Allow Off-label Promotion
  • Jan 23, 2019
    DePuy Reaches $120 Million Consent Judgment with States
  • Jan 22, 2019
    Study Finds Connection between Opioid Marketing to Physicians and Overdose Deaths
  • Jan 18, 2019
    Washington State Legislators Consider Drug Price Transparency Bills
  • More

Good Clinical Practice

  • Mar 20, 2019
    FDA Issues Two Final Guidances on HIV Trials
  • Mar 19, 2019
    Groups Release Recommendations To Aid Lupus Trials
  • Mar 16, 2019
    New Approach Needed for Subject Incentive Payments
  • Mar 15, 2019
    FDA Provides Answers to Risk-based Monitoring Questions
  • Mar 14, 2019
    FDA Releases Four Draft Guidances on Cancer Trial Eligibility Criteria; Final Guidance on Age Limits
  • Mar 13, 2019
    U.K. Guidance Details Handling IMP With No Brexit Deal
  • Mar 12, 2019
    NCI Director Sharpless To Serve as Acting FDA Commissioner Following Gottlieb’s Departure
  • Mar 7, 2019
    Florida Bill Requires Reimbursement Discussion for Cancer Clinical Trials
  • Mar 6, 2019
    CDER Planned 2019 Guidance Includes Clinical Trial Topics
  • Mar 5, 2019
    Gottlieb Resigns as FDA Commissioner
  • More

U.S. Food Labeling

  • Oct 28,2015
    Oregon Sues GNC Over the Alleged Use of Unapproved Ingredients, Labeling Violations
  • Oct 21,2015
    Companies Have Eight Months To Add Selenium To Formula Labels
  • Oct 21,2015
    WLF Takes on Added Sugar Proposal, Levels Free Speech Accusations
  • Oct 13,2015
    State Legislators Rail Against GMO Labeling Preemption Bill in Open Letter to Congress
  • Oct 8,2015
    GMA: FDA Accepts Trans Fat Petition, Agrees To Consider GRAS Exemption
  • Oct 7,2015
    Senate Committee Sets Hearing Concerning GMO Regulations
  • Sep 29,2015
    States Rush To Support Vermont in GMO Labeling Fight
  • Sep 22,2015
    Ex-CEO of PCA Gets 28 Years for Role in 2009 Salmonella Outbreak
  • Sep 17,2015
    FDA Draft Guidance Delves Into Menu Labeling But Offers Little New Insight
  • Sep 15,2015
    Obama Nominates Dr. Robert M. Califf as Next FDA Commissioner
  • More

FDA Regulation & Enforcement

  • Jun 23, 2022
    Members of Congress Want Changes to Plant-Based Milk Guidance Before Release
  • Jun 20, 2022
    FTC Enforcement To Focus on PBM Rebates and Fees
  • Jun 16, 2022
    Vermont Compounding Pharmacy Barred from Distributing Drugs Until It Comes Into Compliance
  • Jun 15, 2022
    Connecticut Supreme Court Recognizes State Duty To Report Device Adverse Events to the FDA
  • Jun 10, 2022
    Washington Supreme Court: Direct-to-Consumer Advertising Does Not Dilute Learned Intermediary Doctrine
  • Jun 9, 2022
    Former Lilly Employee Alleges Retaliatory Termination Following Her Probes Into cGMP Violations
  • Jun 9, 2022
    Bill Would Create FDA-Managed Dietary Supplement List
  • Jun 7, 2022
    Third OPDP Untitled Letter of 2022 Cites Risk Presentation, Efficacy Claims
  • Jun 2, 2022
    Pfizer Reaches Kansas Settlement Over Co-pay Coupon Program
  • Jun 1, 2022
    S.C. Supplement Company Owner Pleads Guilty to Illegally Distributing SARMs, Other Steroids
  • More

Medical Devices

  • Aug 1, 2018
    Minnesota Court Holds at Summary Judgment Stage that Tort Claims Involving PMA Device Are Preempted
  • Aug 1, 2018
    FDA Sends Letters to Seven Device Makers Questioning Off-label Marketing
  • Jul 30, 2018
    Device User Fee Rates Return to Modest Increases for FY 2019 Following Previous Year’s Steep Hikes
  • Jul 26, 2018
    House Votes for Full Repeal of Device Excise Tax
  • Jul 24, 2018
    AngioDynamics Inc. Agrees To Settle False Claims Allegations Related to Two Devices for $12.5 Million
  • Jul 17, 2018
    Court: Failure-To-Warn Claim Based on Alleged Noncompliance with Device Reporting Mandates Is Not Preempted
  • Jul 11, 2018
    Legislation Would Require Three Years of Initial Medicare Coverage for Breakthrough Devices
  • Jul 5, 2018
    Encouraging Standardization, FDA Provides Guidance on Use of LOINC Codes With IVD Tests, EHRs
  • Jun 28, 2018
    HHS: Program Providing Free Samples of Ostomy Products Presents Low Risk of Fraud and Abuse
  • Jun 27, 2018
    Court Dismisses Fraud Suit Alleging that 510(k) Device Was Falsely Represented as Safe and Effective
  • More

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