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Advertising & Promotion

  • Aug 1, 2018
    FDA Sends Letters to Seven Device Makers Questioning Off-label Marketing
  • Jul 31, 2018
    Michigan Bill Adds Drug Products to State Consumer Protection Act
  • Jul 31, 2018
    Concern Raised Over Proposals To List Prices in DTC Drug Ads
  • Jul 25, 2018
    Australian Survey Finds Only Half of Health Consumer Groups Identify Industry Donors
  • Jul 25, 2018
    CVM Issues Two Untitled Letters for Website Concerns
  • Jul 24, 2018
    AngioDynamics Inc. Agrees To Settle False Claims Allegations Related to Two Devices for $12.5 Million
  • Jul 21, 2018
    ERSP Supports Some Claims for Anti-Nausea Product; Asks Company To Modify, Discontinue Other Claims
  • Jul 18, 2018
    NAD Recommends Discontinuing OTC Allergy Product Claims After Competitor Challenge
  • Jul 18, 2018
    NAD Recommends Company Discontinue Claims, Testimonials for Supplement
  • Jul 12, 2018
    U.S. Attorney Files Complaint Against Supplement Maker
  • More

Good Clinical Practice

  • Oct 23, 2018
    NIA Issues Strategy for Alzheimer’s Disease Trial Recruitment
  • Oct 23, 2018
    District Court Dismisses CRS Case Over Additional Informed Consent Disclosures
  • Oct 22, 2018
    SACHRP Recommends Elevating OHRP Within HHS
  • Oct 22, 2018
    SACHRP Examines Revised Common Rule Requirement for Key Information To Be Provided in Informed Consent
  • Oct 22, 2018
    Young Adults Missing Out on Cancer Trials
  • Oct 22, 2018
    SACHRP Examines Parental Permission for Greater Than Minimal Risk Pediatric Research With No Benefit
  • Oct 22, 2018
    SACHRP Provides Recommendations on First Two Exemptions in Revised Common Rule
  • Oct 19, 2018
    SACHRP Makes Recommendations on How To Transition to New Common Rule
  • Oct 18, 2018
    NPRM To Harmonize FDA Regulations With Revised Common Rule Set for June Release
  • Oct 18, 2018
    CBER Sends Warning Letter to Investigator
  • More

U.S. Food Labeling

  • Aug 21,2014
    GMO Labeling Measure To Appear on the Ballot in Colorado
  • Aug 18,2014
    CFSAN: Company Made Drug-like Labeling Claims, Omitted Trans Fat Information
  • Aug 14,2014
    AMS Considers Tweaks to Beef Grading To Improve Accuracy of Label Information
  • Aug 11,2014
    Vermont Says Industry Suit Over GMO Disclosure Label Should Be Dismissed
  • Aug 8,2014
    Lawmakers: FDA Should Mandate Front of Package Labeling, Set Definition for ‘Natural’
  • Aug 6,2014
    Oregon GMO Labeling Measure Goes on the November Ballot
  • Aug 4,2014
    Enforcement Moratorium on ‘Gluten-free’ Claims Ends Aug. 5
  • Jul 31,2014
    Appellate Court Upholds USDA's COOL Rule Changes
  • Jul 21,2014
    House Subcommittee: GMO Labeling Efforts Rooted in Misinformation
  • Jul 17,2014
    Former FDA Chief, Ex-CDC Official Seek More Nutrition Facts Changes
  • More

FDA Regulation & Enforcement

  • Oct 29, 2021
    Arizona Settles with Three Physicians Over Insys Speaker Program
  • Oct 28, 2021
    OPDP Researchers To Examine Influence of Targeted Mechanism of Action Claims, Graphics and Disclosures
  • Oct 28, 2021
    HHS OIG: Medicare Co-Pay Subsidies for Alzheimer’s Disease Study Subjects Would Not Trigger Sanctions
  • Oct 28, 2021
    Supplement Firm Enjoined From Selling Violative Products
  • Oct 21, 2021
    FTC Puts Industry on Notice About Endorsements
  • Oct 21, 2021
    Fifth Circuit Affirms Dismissal on Preemption Grounds of Tort Claims Stemming from ICD Failure
  • Oct 20, 2021
    Court Backs Pharmacies’ Challenge to Finalized FDA MOU Requiring State Policing of Drug Compounding
  • Oct 20, 2021
    Court Backs Pharmacies’ Challenge to Finalized FDA MOU Specifying State Policing of Drug Compounding
  • Oct 14, 2021
    FDA Develops Quiz To Promote Bad Ad Program
  • Oct 14, 2021
    DOJ Reaches Civil Settlements with Three Generic Drug Makers Accused of Conspiring To Fix Prices
  • More

Medical Devices

  • Mar 22, 2017
    House Members Release Draft of Bill To Establish ‘Flexible’ Regulation of In Vitro Clinical Tests
  • Mar 16, 2017
    FY 2018 Budget Proposes Doubling of User Fees for FDA’s Medical Product Premarket Reviews
  • Mar 14, 2017
    FDA Offers First Set of Devices To Be Exempted from 510(k) Mandates Under Cures Act
  • Mar 12, 2017
    Gottlieb Nominated To Head FDA as Commissioner of Food and Drugs
  • Mar 9, 2017
    FDA Issues Safety Communication on Use of Angioplasty Devices in Treatment of Neurological Disorders
  • Mar 1, 2017
    Court: Patient Cannot Sue Surgery Center for Returning Faulty Device to Its Manufacturer
  • Feb 28, 2017
    DOJ Posts Detailed Guidance on How It Evaluates Corporate Compliance Programs
  • Feb 23, 2017
    Legislation Would Establish Risk-Based Scheduling of FDA’s Medical Device Establishment Inspections
  • Feb 15, 2017
    GAO Report on Power Morcellators Details Limitations of FDA’s Device Adverse Event Reporting System
  • Feb 8, 2017
    FDA Is Reviewing Implantable Infusion Pump Labeling Following Adverse Events Linked to MRI Exams
  • More

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