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Advertising & Promotion

  • Sep 21, 2017
    Coalition of 41 State Attorneys General Broadens Investigation into Opioid Makers, Distributors
  • Sep 18, 2017
    Gottlieb Signals Changes in FDA Advertising, Promotion Policy
  • Sep 14, 2017
    NAD Recommends Firm Discontinue Claims for Hair Restoring Laser Device; Settles Who’s No. 1 Dispute
  • Sep 13, 2017
    FDA Needs To Resolve First Amendment Issues: Gottlieb
  • Sep 12, 2017
    Galena Settles False Claims Case Over Abstral Marketing
  • Sep 9, 2017
    FTC Updates Endorsement Guide with Social Media Influencer Questions
  • Sep 9, 2017
    New Mexico Sues Opioid Manufacturers, Distributors
  • Sep 7, 2017
    McCaskill Releases First Report from Opioid Marketing Investigation
  • Sep 6, 2017
    N.J. Proposes Reg To Cut Physician Meals and Industry Compensation
  • Sep 6, 2017
    First 2017 OPDP Warning Letter Sent To Canadian Opioid Manufacturer
  • More

Good Clinical Practice

  • Jan 23, 2018
    NIH Task Force Considers Research Specific to Pregnant and Lactating Women
  • Jan 23, 2018
    EMA Releases Guideline on RA Trials
  • Jan 20, 2018
    Washington Bill Targets Recruitment of Underrepresented Groups in Trials
  • Jan 19, 2018
    CDER Plans Guidance on Adaptive Design, Pregnant Women and Other Research Topics
  • Jan 19, 2018
    Grassley Sends Letter Questioning OHRP, FDA Oversight of Vaccine Research
  • Jan 19, 2018
    Va. Bill Mandates State Insurance Coverage for Hypofractionated Proton Therapy Trials
  • Jan 18, 2018
    Mississippi Bills Require State Research To Follow Common Rule
  • Jan 18, 2018
    Revised Common Rule Implementation Pushed to July; More Delay Expected
  • Jan 16, 2018
    Federal Right-to-Try Legislation Could Threaten FDA’s Mission
  • Jan 16, 2018
    FDA Revised Rule on Device Clinical Data Expected in March
  • More

U.S. Food Labeling

  • May 31,2012
    Get Your Newsletter Faster Online!
  • May 31,2012
    Kashi Commits to GMO-Free Product Line by 2015
  • May 31,2012
    FSIS Launches Online Label Submission System
  • May 31,2012
    Mandatory Labeling of Genetically Engineered Foods To Be on California Ballot in November
  • May 31,2012
    Initial Decision in FTC vs POM Wonderful Case Leaves Both Sides Claiming Victory
  • May 31,2012
    Alcoholic Drinks Must Disclose Cochineal Extract And Carmine Color Additives on Labels
  • May 31,2012
    FDA Warns 10 Companies about Selling Dietary Supplements Containing DMAA
  • May 31,2012
    Product Recalls
  • Apr 30,2012
    Sales of Organic Foods Up 9.4% in 2011; Continue To Outpace Sales Growth of Conventional Foods
  • Apr 30,2012
    Nutella Manufacturer Settles Class Action Lawsuit
  • More

FDA Regulation & Enforcement

  • Sep 10, 2020
    Former Indivior Medical Director Pleads Guilty to Misbranding Charge Brought Under Park Doctrine
  • Sep 9, 2020
    Judge Grants Preliminary Injunction in Marketing Case
  • Sep 3, 2020
    Groups, Retailers Ask Court To Force AMS To Rework GMO Rulemaking
  • Sep 2, 2020
    DUSA Pharmaceuticals To Pay $20.75 Million To Resolve Allegations That It Promoted Unapproved Administration of Its Drug
  • Aug 28, 2020
    OPDP Issues First 2020 Untitled Letter Over DTC TV Ad for Diabetes Product
  • Aug 27, 2020
    FDA Outlines Inspection Policy for Drugs, Biological Products During COVID-19 Public Health Emergency
  • Aug 21, 2020
    AbbVie Settles California Insurance Suit Over Promotion of Humira
  • Aug 17, 2020
    FDA Publishes Rule for ’Gluten-Free’ Labeling of Fermented, Hydrolyzed Foods
  • Aug 15, 2020
    Ninth Circuit Rejects Preemption Defense, Finding Special Controls Were Not Specific to the Device
  • Aug 14, 2020
    Specialty Pharmacy Agrees to $3.5 Million Settlement of Kickback Allegations Involving Teva Drug
  • More

Medical Devices

  • Feb 11, 2015
    Medtronic Settles Allegations over Unapproved Pain Relief Procedure for $2.8 Million
  • Feb 10, 2015
    FDA Confirms Intention Not To Enforce Requirements for Medical Device Data Systems
  • Feb 5, 2015
    Device Companies Enter Into Consent Decree With FDA To Resolve QS, Other Allegations
  • Feb 4, 2015
    CDRH Strategic Priorities Update Touts Faster IDE Approvals, Other Improvements in FY 2014
  • Feb 4, 2015
    FY 2016 FDA Device Budget Calls for International Courier User Fee, Funding for Precision Medicine
  • Feb 3, 2015
    Device Makers Invited To Be Part of Single Audit Pilot; FDA, Three Other Authorities Participating
  • Feb 2, 2015
    FDA Expands Online System for Requesting Device Export Certificates, Other Documents
  • Jan 28, 2015
    CDRH Wants Dramatic Improvements in IDE Approvals
  • Jan 28, 2015
    Draft Guidance Offers Recommendations for Meeting Combination Product cGMP Requirements
  • Jan 22, 2015
    Draft Guidance Proposes Treatment of Device Accessories, General Wellness Products
  • More

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