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Advertising & Promotion

  • Jan 24, 2018
    More Civil Entities Sue Over Opioid Marketing
  • Jan 23, 2018
    OPDP Issues Untitled Letter to UCLA Over Investigational Drug Promotion
  • Jan 23, 2018
    Kentucky Bill Prohibits Opiate Advertising
  • Jan 22, 2018
    Device Trade Groups Eliminate ‘Direct Sponsorship’ of Individuals for Educational Events
  • Jan 19, 2018
    CDER 2018 Draft Guidance Plan Includes Two Advertising Guidances
  • Jan 18, 2018
    House Subcommittee Approves PIE Act
  • Jan 18, 2018
    N.J. Senate Resolution Introduced Calling for DTC Advertising Ban
  • Jan 18, 2018
    Tribes Sue Drug Makers Over Opioid Marketing
  • Jan 17, 2018
    N.J. Rules on Prescriber-Company Interaction Take Effect
  • Jan 17, 2018
    FTC Issues Guidance on Multi-level Marketing
  • More

Good Clinical Practice

  • May 27, 2018
    EMA Issues Guidance on Handling and Shipping IMP
  • May 25, 2018
    House Approves Senate Version of ‘Right-to-Try’
  • May 23, 2018
    FDA Issues Guidance on Trials for Drugs for CMV in Organ Transplant Patients
  • May 23, 2018
    Rhode Island House Passes ‘Right-to-Try’ Bill
  • May 17, 2018
    FDA, OHRP Issue Final Guidance for IRB Written Procedures
  • May 17, 2018
    ORI Finds Researcher Used Own Blood for Samples in Cancer Genetics Study
  • May 15, 2018
    FDA Issues Draft Guidance on uUTI Trials
  • May 15, 2018
    FDA Issues Draft Guidance on HIV Pediatric Trials
  • May 10, 2018
    District Court Denies CRS Complaint Against FDA Over Request to Update Informed Consent Regulations
  • May 10, 2018
    FDA Plans Clinical Trial Reg Changes
  • More

U.S. Food Labeling

  • Mar 28,2013
    House Bill Proposes New Limits on Menu Labeling
  • Mar 27,2013
    Monster Beverage Prepping for Nutrition Facts Labels Amid Transition to Conventional Food-status
  • Mar 20,2013
    POM Wonderful Appeals FTC Order Restricting Unproven Promotional Claims
  • Mar 20,2013
    POM Wonderful Appeals FTC Order Restricting Unproven Promotional Claims
  • Mar 18,2013
    FDA Shoots Down Petition Angling For Mercury-content Labels on Fish
  • Mar 18,2013
    FSIS Preparing To Furlough Employees To Handle Sequestration Funding Loss
  • Mar 18,2013
    Whole Foods Grocery Chain Pledges GMO Labeling Disclosure for Products by 2018
  • Mar 13,2013
    USDA Proposes New Labeling Disclosures for Meat Producers in the U.S. To Comply With WTO Ruling
  • Feb 25,2013
    CFSAN Rescinds 2006 Guidance Granting Enforcement Leniency for Lecithin Labels
  • Feb 22,2013
    JAMA Journal Article Suggests Vitamin D Labels Frequently Conflict With Actual Potency
  • More

FDA Regulation & Enforcement

  • Feb 17, 2021
    EHR Developer Settles Kickback Case
  • Feb 11, 2021
    India-Based API Manufacturer Pleads Guilty to Concealing, Destroying Records Before FDA Inspection
  • Feb 6, 2021
    McKinsey Agrees to $573 Million Settlement Over Opioid Promotion
  • Feb 4, 2021
    FDA Launches Process for Communicating Findings from 704(a)(4) Record Requests to Drug Sponsors
  • Feb 4, 2021
    Suits Filed Against Chain Stores Allege Improper Labeling of Store-Brand Products
  • Feb 3, 2021
    Insys Therapeutics Founder Kapoor Settles with New Jersey in Opioids Lawsuit
  • Feb 3, 2021
    Massachusetts High Court Sets Broad Standard Against Preemption But Finds Claims Not To Be Plausible
  • Jan 28, 2021
    Ninth Circuit Rejects on Preemption Grounds Allegation that Biotin Structure/Function Claim Was Deceptive
  • Jan 27, 2021
    Acting Director Wants OPDP To Be More Visible
  • Jan 22, 2021
    Woodcock Becomes Acting FDA Commissioner Following Hahn’s Resignation as Biden Administration Begins
  • More

Medical Devices

  • Jan 5, 2016
    CDRH Proposes System for Release of ‘Emerging’ Postmarket Information about Medical Devices
  • Dec 29, 2015
    CDRH Sets Device Guidance Development Priorities for FY 2016, Calls for Early Stakeholder Input
  • Dec 18, 2015
    President Signs Two-Year Moratorium on Device Excise Tax Into Law
  • Dec 17, 2015
    Government Funding Proposal Includes Two-Year Moratorium on Medical Device Excise Tax
  • Dec 8, 2015
    eCopy Guidance for Device Submissions Revised in Response to Consulting Firm's Assessment
  • Dec 2, 2015
    FDA Seeks Support for its Proposed Framework for Regulating Laboratory-Developed Tests
  • Nov 24, 2015
    FDA Reports Nine Deaths Associated With Coating Separations, Urges Provider Caution
  • Nov 16, 2015
    Court: Claims Against Device Manufacturer Not Blocked by Texas Health Care Tort Reform Law
  • Nov 12, 2015
    FDA Continues To Shift Quality System Device Inspection Resources Toward Foreign Facilities
  • Nov 5, 2015
    FDA Calls for Stakeholder Input on Improving Combination Product Review Procedures
  • More

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