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Advertising & Promotion

  • Apr 5, 2016
    OPDP Warning Letter Cites Lack of Risk Information in Shionogi Voucher for Head Lice Lotion
  • Apr 1, 2016
    Review Finds Drug Settlement Penalties Down in Last Two Years
  • Mar 26, 2016
    Survey Finds Millennials More Receptive To Drug Marketing Than Other Generations
  • Mar 21, 2016
    FDA Needs To Rethink Position, Issue Clearer Guidance on Off-label Promotion, Experts Say
  • Mar 18, 2016
    Article Contends ‘Informativeness’ Should Be ‘Off-label’ Promotion Standard
  • Mar 17, 2016
    Minnesota Considers Cost Reporting for High-Priced Drugs
  • Mar 17, 2016
    FDA Responds to Comments on Planned Studies of Understanding of Quantitative Info in TV DTC Ads
  • Mar 17, 2016
    FTC Approves Final Consent Order Over Claims Made for ‘Ultimeyes’ App
  • Mar 16, 2016
    NAD Refers New Nordic Ad Claims to FTC
  • Mar 9, 2016
    FDA Plans To Study Use of Superimposed Text in DTC Ads
  • More

Good Clinical Practice

  • Jan 19, 2017
    Final Common Rule for Protection of Human Subjects Issued; Some Contentious Proposals Are Omitted
  • Jan 12, 2017
    N.Y. Bill Looks To Start Fund To Aid Clinical Trial Access
  • Jan 12, 2017
    IBM-FDA Sign Blockchain Research Pact
  • Jan 12, 2017
    ASCO Calls for Access To Clinical Trials With No Insurance Coverage Barriers
  • Jan 12, 2017
    Survey Finds Doctors, Nurses Comfortable Discussing Trials But Not Making Referrals
  • Jan 12, 2017
    NCI Launches Formulary To Speed Researcher Access To Agents for Clinical Trials
  • Jan 11, 2017
    FDA Offers Flyer Encouraging Clinical Trial Participation
  • Jan 10, 2017
    Appeals Court Finds Company’s Discussion of Clinical Trial Plans Did Not Mislead Shareholders
  • Jan 9, 2017
    OHRP Details Incidents and Corrective Actions Reported
  • Jan 9, 2017
    Researchers Develop Database To Search Clinical Trial Data in FDA DAPs
  • More

FDA Regulation & Enforcement

  • Jun 20, 2019
    Guidance Issued for Labeling Single-Ingredient Honey, Syrup, Cranberries
  • Jun 19, 2019
    Florida Is Third State To Authorize Importation of Prescription Pharmaceuticals from Canada
  • Jun 15, 2019
    Drug Companies Sue To Stop Price Listing in DTC Ads
  • Jun 15, 2019
    ABPI Issues Guide To Working with Patient Groups
  • Jun 14, 2019
    Senate Bill Would Require Cost Reporting; Provide Funds for Clinical Trials
  • Jun 13, 2019
    ACell Inc.’s Failure To Report Removal of Wound Dressing Product to FDA Leads to $15 Million Settlement
  • Jun 13, 2019
    AMS Clarifies Certification of Organic Crop Container Systems Under NOP
  • Jun 13, 2019
    TGA Issues Guidance on Use of ‘Natural’ in Medical Product Ads
  • Jun 12, 2019
    District Court Overturns Convictions of Two NECC Officials for Conspiracy To Defraud the FDA
  • Jun 10, 2019
    Senate Bill Imposing Penalties on ‘Dubious’ Opioid Marketing Introduced
  • More

Medical Devices

  • Sep 30, 2011
    NIH Issues New Conflict of Interest Guidelines
  • Sep 30, 2011
    FDA: Sponsor Should 'Justify' Pivotal Study Design
  • Sep 30, 2011
    Reps Want Review of Wireless Device Oversight
  • Sep 30, 2011
    FDA Favors Centralized Clinical Trial Monitoring
  • Sep 30, 2011
    FDA Issues Draft Guidance on 522 Postmarket Studies
  • Sep 30, 2011
    CMS To Expand Competitive Bidding Program for Round 2
  • Aug 31, 2011
    FDA Finally Issues Draft Guide on When a New 510(k) Submission Is Required for Changes to a Cleared Device
  • Aug 31, 2011
    FDA To Increase Oversight of Mobile Medical Apps
  • Aug 31, 2011
    510(k) Program Cannot Be Salvaged, IOM Tells FDA
  • Aug 31, 2011
    FDA Says Industry To Blame for Slow 510(k) Review Times
  • More

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