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Advertising & Promotion

  • Dec 22, 2015
    FDA Opens New Dietary Supplement Office
  • Dec 16, 2015
    Reassessing Advertising and Promotion Is a 2016 CDER ‘Front-burner’ Priority
  • Dec 15, 2015
    Pacira-FDA End Warning Letter Squabble
  • Dec 10, 2015
    European Device Manufacturers Adopt New Code of Ethical Business Practices
  • Dec 2, 2015
    Tommie Copper Settles FTC Deceptive Ad Case
  • Dec 2, 2015
    Economics Paper Examines DTC Impact
  • Nov 25, 2015
    NAD Recommends Discontinuation of Claims for Skin Filler
  • Nov 25, 2015
    Dr. Reddy Sues AstraZeneca over Nexium
  • Nov 24, 2015
    CVM Issues First Promotion-related Advisory Letter in Nearly Two Years
  • Nov 18, 2015
    Federal Sweep Targets Dietary Supplements
  • More

Good Clinical Practice

  • Nov 7, 2016
    FDA Final Guidance on Neurological Device Studies Is Little Changed from Draft Guidance
  • Nov 5, 2016
    AllTrials Launches Website Tracking Trial Result Reporting
  • Nov 2, 2016
    FDA Updates Guidance on Race and Ethnicity Data
  • Nov 2, 2016
    FDA Releases Guidance on Trials for Drugs Treating Low Sexual Drive in Women
  • Nov 2, 2016
    ORO Wants To Work with Other Common Rule Agencies To Develop Guidelines for Deceased Donor Research
  • Nov 1, 2016
    Panel Reviewing Data-sharing Requests Finds Little Interest, Few Published Papers
  • Nov 1, 2016
    SCRS Releases Dashboard for Study Site Metrics, Recommendations for Site Payment and CTA Language
  • Oct 31, 2016
    JAMA Viewpoint Details How to Better Report Sex and Gender in Studies
  • Oct 31, 2016
    SACHRP Finds NIH Change on Review of Gene Transfer Research Places ‘Additional Burden’ on IRBs
  • Oct 31, 2016
    HHS Guidance Is Needed for Determining Whether ‘Benchmarking’ Projects Are Research Under HHS Rules
  • More

FDA Regulation & Enforcement

  • May 9, 2019
    Stakeholders Want Details on Labeling Cell Cultured Food
  • May 8, 2019
    Many Question CMS’ Authority To Promulgate Rule
  • May 8, 2019
    CMS Examines First Amendment Concerns Over Final Rule Requiring Pricing Information in DTC TV Ads
  • May 8, 2019
    FDA Moves Ahead with Study of DTC Disclosures for Accelerated Approval Products
  • May 8, 2019
    CMS Publishes Final Rule Requiring Pricing Info in DTC TV Drug Ads
  • May 8, 2019
    Unsealed Qui Tam Suit Alleges Off-Label Marketing
  • May 6, 2019
    Bill Prohibiting Drug Advertising Introduced in Maine Senate
  • May 6, 2019
    Specialty Drug Company Will Pay $17.5 Million To Settle Kickback Allegations
  • May 4, 2019
    Insys Founder, Four Former Executives Found Guilty of RICO Conspiracy
  • May 4, 2019
    Hospitals Sue Over Opioid Marketing
  • More

Medical Devices

  • Mar 31, 2011
    FDA Moves To Downclassify Data Systems
  • Feb 28, 2011
    CDRH Identifies Four Priority Areas for FY 2011
  • Feb 28, 2011
    Competitive Bidding Program Relaunched on Schedule, But Beneficiary Complaints About Service Are Mounting
  • Feb 28, 2011
    CDRH Commits to 25 Changes to 510(k) Program
  • Feb 28, 2011
    Guidant Now Facing Civil Lawsuit Over Faulty ICDs
  • Feb 28, 2011
    FDA Posts Status of Preamendment Devices
  • Jan 31, 2011
    19 FDA Actions Items for 2011 To Improve Transparency
  • Jan 31, 2011
    Federal Court: Claims Involving IDEs Are Preempted
  • Jan 31, 2011
    Final Rule Requires Information on ClinicalTrials.gov To Be Included in Informed Consent Documents
  • Jan 31, 2011
    CMS Proposes Covering MRI Use in Specific Trials
  • More

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