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Advertising & Promotion

  • Sep 6, 2017
    Novo Nordisk Agrees to Pay $58 Million Over Failure to Comply With FDA-Mandated REMS
  • Sep 5, 2017
    Law Review Article Pushes Risk-based Approach to Evaluating Medical Product Advertising Claims
  • Sep 2, 2017
    Company, Individuals Settle FTC, Maine Charges Over Health Supplement Promotion
  • Sep 1, 2017
    Australia To Revise Medical Product Ad Code
  • Aug 31, 2017
    Missouri Expands Opioid Marketing Case
  • Aug 24, 2017
    Insys Reaches $4.45 Million Settlement With Illinois Over Opioid Marketing
  • Aug 18, 2017
    FDA Opens Public Comment on Communicating Risk Info in DTC Broadcast Ads for Drugs and Biologics
  • Aug 18, 2017
    PhRMA Says FDA Needs Clear Research Agenda Regarding Advertising and Promotion Studies
  • Aug 17, 2017
    S.C. Sues Purdue Pharma Over Opioid Marketing
  • Aug 12, 2017
    PhRMA Releases 2017 DTC Ad Survey Results
  • More

Good Clinical Practice

  • Jan 16, 2018
    Researchers Need To Report Their Own Gender in Published Studies
  • Jan 16, 2018
    FDA Starts Pilot Program for Posting CSRs
  • Jan 15, 2018
    Analysis Finds More Timely Reporting of Trial Results to ClinicalTrials.gov
  • Jan 15, 2018
    Review Finds No Systematic Underrepresentation of Women in Trials
  • Dec 30, 2017
    Guidelines for Brain Cancer Clinical Trial Design Proposed
  • Dec 30, 2017
    Researchers Find Retrospective Consent Increases Participation in Neonatal Trial
  • Dec 29, 2017
    FDA Releases Two Guidances To Aid IND Sponsor-Agency Interaction
  • Dec 29, 2017
    Survey Finds Fewer Subjects Will Recommend Trial Participation
  • Dec 29, 2017
    JAMA Viewpoint Contends Expanded Subgroup Research Is Critical
  • Dec 23, 2017
    FDA Starts Patient Engagement Collaborative
  • More

U.S. Food Labeling

  • Apr 30,2012
    Product Recalls
  • Apr 30,2012
    House Members Call for Mandatory Labeling of LFTB ('Pink Slime') in Ground Beef Products
  • Apr 30,2012
    USDA Says No Changes in COOL Requirements For Meat Products Despite WTO Decision
  • Apr 30,2012
    FDA Urged To Stop Lemon Juice Labeling Abuses
  • Apr 30,2012
    Following NAD Decision, ConAgra Will Drop Comparative Claims for Lasagna Product
  • Mar 31,2012
    Meat Industry Mostly Likes FSIS's Proposed Rule To Streamline Labeling Approval Process
  • Mar 31,2012
    Judge Denies Motion To Dismiss Quaker Oats Suit
  • Mar 31,2012
    FDA Warns Ice Cream Firm over Labeling Violations
  • Mar 31,2012
    Product Recalls
  • Mar 31,2012
    Big Cola Companies Modify Caramel Coloring Process To Avoid Cancer Warning Labels
  • More

FDA Regulation & Enforcement

  • Aug 14, 2020
    Congressional Bills Seek Opioid Sales Rep Licensure; State Bills Would Ban HCP Gifts
  • Aug 12, 2020
    Eight Individuals Indicted for Alleged Clinical Research Fraud Against FDA, Pharmaceutical Companies
  • Aug 12, 2020
    FDA Offers Guidance on Importing Medical Devices During the COVID-19 Public Health Emergency
  • Aug 7, 2020
    Citizen Petition Requests FDA Ban on Music During Risk Presentation in DTC Ads
  • Aug 6, 2020
    AMS Releases Proposal To Buttress NOP Enforcement, Improve Traceability
  • Aug 5, 2020
    Grassley To Propose Bill To Curb Department of Justice Practice of Dismissing False Claims Suits
  • Jul 31, 2020
    Pacira Settles Kickback Allegations Over Research Grants
  • Jul 30, 2020
    AMS Seeks Comments on Updates to NBFDS List of Bioengineered Foods
  • Jul 29, 2020
    Indivior Agrees To Plead Guilty, Pay $600 Million as Part of Largest-Ever DOJ Settlement Involving an Opioid
  • Jul 28, 2020
    Device False Advertising Claims Dismissed
  • More

Medical Devices

  • Jan 14, 2015
    FDA Cannot Regulate Laboratory-Developed Testing Services as Devices, Counsel for Association Argue
  • Jan 14, 2015
    HHS OIG To Evaluate Medicare Beneficiary Access to DMEPOS Under CMS Competitive Bidding Program
  • Jan 8, 2015
    CDRH Announces FY 2015 Guidance Development Plans
  • Jan 8, 2015
    CAPA, Complaint Procedure Issues Remain the Top Two Inspectional Observations for Devices
  • Dec 23, 2014
    Draft Guidance Offers Recommendations on Meeting Notification Obligations for Transferred 510(k)s
  • Dec 18, 2014
    CDRH Issues Updated Guidance on Testing, Labeling Implants With Respect to Dangers from MRIs
  • Dec 10, 2014
    FDA Finalizes Guidance on Labeling Devices Not Made with Latex
  • Dec 3, 2014
    Grand Jury Indicts Device Manufacturer, CEO, Alleging Off-label Marketing, Conspiracy To Defraud
  • Dec 2, 2014
    FDA Extends UDI Mandate Compliance Date for Some Implantable Orthopedic Devices to September 2016
  • Nov 20, 2014
    Critics of LDT Draft Guidance Call for FDA To Conduct Full Notice-and-Comment Rulemaking
  • More

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