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Advertising & Promotion

  • May 9, 2017
    Gottlieb Confirmed by Senate as New FDA Commissioner
  • May 9, 2017
    FDA Draft Payor’s Guidance Doesn’t Go Far Enough, Needs Clarification
  • May 3, 2017
    Restrictions on Drug Detailing Result in ‘Modest’ Changes in Prescribing Behavior
  • May 3, 2017
    Court Dismisses False Claims Complaint Based on Data From ‘Deceptive’ Study of Physician Prescribing
  • May 2, 2017
    Oregon Bill Requiring Wholesale Price Disclosure in Ads Dies in Committee
  • Apr 27, 2017
    Pharmacist Pleads Guilty To Conspiracy To Pay Healthcare Kickbacks
  • Apr 26, 2017
    Work of Health Fraud Teams Across FDA Produces 18 Enforcement Letters Targeting Bogus Cancer Claims
  • Apr 19, 2017
    Pa. Senate Bill Requires Annual Drug Cost Reporting, Establishes Commission To Review Prices
  • Apr 19, 2017
    DTC TV Ad Policy Faces Challenges at 20
  • Apr 17, 2017
    California Legislature Considers Drug Reporting
  • More

Good Clinical Practice

  • Nov 3, 2017
    Proposed Tax Reform Bill Has Research Implications
  • Nov 1, 2017
    Reps. Question Post-Market Safety Study
  • Nov 1, 2017
    N.J. Formally Proposes Regulation Capping Physician Payments and Limiting Meal Costs
  • Oct 30, 2017
    FDA Draft Guidances Provide Risk-based Approach To Evaluating Drug Interactions
  • Oct 30, 2017
    FDA Considers Streamlining §50.54 Process
  • Oct 27, 2017
    EMA Details Year of Clinical Data Access
  • Oct 27, 2017
    CRS Sues FDA To Update Consent Regs
  • Oct 26, 2017
    Janssen Unveils Toolset To Automate Trial Product Supply and Data Management
  • Oct 26, 2017
    OHRP To Report Noncompliance Allegations to HHS OIG or Funding Agency
  • Oct 24, 2017
    ClinicalTrials.gov Add Six FAQs on Trial Registration and Results Submission
  • More

U.S. Food Labeling

  • Oct 31,2011
    IOM Report on FOP Symbols Recommends Scoring System Based on Fats, Sodium and Added Sugars
  • Oct 31,2011
    FDA Commissioner Puts Spotlight on Revised Nutrition Facts Panel and Sodium Reduction
  • Oct 31,2011
    Lawsuit Targets General Mills' Fruit Snacks
  • Oct 31,2011
    Petition Urges Mandatory Labeling of GE Foods
  • Sep 30,2011
    Lawsuits Target ConAgra's '100% Natural' Claims For Cooking Oils Made from Biotech Plants
  • Sep 30,2011
    Campbell Settles Lawsuit over Reduced-Sodium Soups
  • Sep 30,2011
    Product Recalls
  • Sep 30,2011
    Proposed Guidelines on Marketing Foods to Kids Facing GOP Opposition on Capitol Hill
  • Sep 30,2011
    FDA Rebukes Corn Refiners for Using 'Corn Sugar' As Alternative Name for HFCS
  • Sep 30,2011
    FDA Warns Cheesecake Maker on Allergens and More
  • More

FDA Regulation & Enforcement

  • Apr 9, 2020
    Pentax Medical Admits to Criminal Misbranding Charge for Noncompliant IFUs, Failure To File MDRs
  • Apr 8, 2020
    Tissue Graft Supplier To Pay $6.5 Million To Resolve Allegations of False Pricing Disclosures to VA
  • Apr 7, 2020
    Court Refuses To Dismiss Criminal Fraud Charges Against Indivior
  • Apr 2, 2020
    FDA, FSIS Offer Labeling Flexibilities in Response to COVID-19
  • Apr 1, 2020
    DOJ Prioritizes Enforcement Targeting COVID-19 Fraud; Court Shuts Down Website Offering Fake Vaccine
  • Apr 1, 2020
    District Court Dismisses Qui Tam Case Against Novartis Over Speaker Program
  • Mar 26, 2020
    Saudi Survey Assesses DTC Advertising
  • Mar 25, 2020
    FDA Will Not Enforce Onsite Audit Mandates Under Three FSMA Regulations During COVID-19 Emergency
  • Mar 18, 2020
    FDA Postpones Most Domestic and Foreign Inspections Because of COVID-19 Public Health Emergency
  • Mar 18, 2020
    FSIS Reaffirms Consistent Use of ‘Healthy’ Claims as Allowed by FDA
  • More

Medical Devices

  • Jun 11, 2014
    ‘First Phase’ of FDA’s Final GUDID Guidance Issued
  • May 30, 2014
    Medtronic Agrees To Pay $9.9 Million To Settle DOJ's Kickback Allegations
  • May 29, 2014
    DOJ Urges Supreme Court Not To Review Lower Court Ruling that Failure-To-Warn Claim Is Not Preempted
  • May 22, 2014
    Senators Ask CMS To Delay Nationwide Implementation of Competitive Bidding Pending HHS OIG Review
  • May 15, 2014
    Proposed Policy Changes Included in Draft Guidance on Consensus Standards in Premarket Submissions
  • May 9, 2014
    Help With Submitting Pediatric Use Information on Devices Provided in New Final FDA Guidance
  • May 7, 2014
    CAPA, P&PC Issues Continued To Dominate QS Regulation 483s, Warning Letters in 2012, FDA Reports
  • May 5, 2014
    CDRH Launches Program for 510(k) eSubmissions
  • May 2, 2014
    What Keeps One Device Company Regulatory VP Up at Night
  • May 2, 2014
    FDA Draft Guidance: Broadcasting the Use of Experimental Devices Is Considered Promotional
  • More

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