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Advertising & Promotion

  • Jun 27, 2018
    Court Dismisses Fraud Suit Alleging that 510(k) Device Was Falsely Represented as Safe and Effective
  • Jun 23, 2018
    Canada Looks To Curb Opioid Marketing
  • Jun 21, 2018
    Company Discontinues Some ‘Hearing Rescue’ Claims for Dietary Supplement After NAD Review
  • Jun 21, 2018
    District Court Allows Lanham False Advertising Case To Continue After Finding No FDA Jurisdiction
  • Jun 16, 2018
    NAD Refers Advertising Claims to FTC for Review
  • Jun 15, 2018
    Massachusetts Sues Purdue CEOs and Directors Over Opioid Marketing
  • Jun 15, 2018
    Final FDA Product Communications Guidance Provides Additional Guidance for Device Manufacturers
  • Jun 15, 2018
    FDA Payor Guidance Discusses Device Concerns and Unapproved Products and Uses
  • Jun 13, 2018
    FDA Issues Final Guidances on Manufacturer Communications
  • Jun 8, 2018
    N.J. Bill Would Require Reporting for Some Drugs
  • More

Good Clinical Practice

  • Oct 1, 2018
    FDA Issues Draft Guidance on Master Protocols for Cancer Trials
  • Sep 30, 2018
    FDA Releases Draft Guidance on Master Protocols and Adaptive Design
  • Sep 29, 2018
    Federally Funded Research May Be a More Cost-Effective Way To Do Pediatric Studies
  • Sep 28, 2018
    CDRH Reopens 10-Year-Old Draft Guidance on Trials for Coronary Drug-Eluting Stents
  • Sep 27, 2018
    UK OKs eConsent
  • Sep 26, 2018
    Data Governance Found To Be a Problem for Trials
  • Sep 26, 2018
    Analysis Estimates Cost of Pivotal Efficacy Trials
  • Sep 25, 2018
    ClinicalTrials.gov Adds Results Question
  • Sep 25, 2018
    FDA Awards 12 Grants for Rare Disease Clinical Trial Research
  • Sep 24, 2018
    ACRP Offers Free Human Subject Protection, Ethics Training as NIH Ends Its Program
  • More

U.S. Food Labeling

  • May 23,2014
    Comment Period Extended on Proposed Revisions to Nutrition Facts Panel
  • May 20,2014
    USDA Proposes Revised Grading System for Maple Syrup Labels
  • May 15,2014
    Report Accuses USDA of Lax Enforcement of Humane Treatment Labeling Claims
  • May 9,2014
    Industry Trade Group Threatens Suit Over Vt. GMO Labeling Law
  • May 8,2014
    Vermont GMO Disclosure Requirements Signed Into Law
  • May 1,2014
    USDA Clarifies Expectations for 'Made With Organic' Labels
  • Apr 24,2014
    Vt. Legislature Passes First Triggerless GMO Labeling Bill, Governor Pledges To Sign Measure
  • Apr 15,2014
    Appeals Court Vacates Earlier Injunction Refusal In COOL Case, Orders Rehearing for May
  • Apr 10,2014
    House Bill Would Prohibit State Efforts To Mandate GMO Disclosure Labels
  • Apr 8,2014
    Draft Guidance: Honey Is a Single-Ingredient Product for Purposes of Labeling Identification
  • More

FDA Regulation & Enforcement

  • Sep 14, 2021
    OPDP Researchers Continue Secondary and Biosimilar Disclosure Studies, Detail Other Research Results
  • Sep 9, 2021
    Former Marketer for Firm Charged with Illegal Drug Sales Pleads Guilty to Conspiracy To Defraud FDA
  • Sep 8, 2021
    Spine Device Maker, Two Company Officials Indicted on Kickback, Conspiracy, Money Laundering Charges
  • Sep 8, 2021
    Federal Enforcement Eying Open Payments Compliance
  • Sep 2, 2021
    Tennessee Court: Liability Claims Involving Hybrid Devices with PMA, 510(k) Components Are Preempted
  • Sep 1, 2021
    Congress Again Moves To Mandate Updates to Food Labeling
  • Sep 1, 2021
    DOJ Revises Policies and Rules on Guidance Documents, Revoking Trump Administration Restrictions
  • Aug 27, 2021
    PhRMA Revises Code Guidelines on Speaker Programs
  • Aug 26, 2021
    Wholesale Co. Owner Charged with Distributing Diverted Rx Drugs to Illinois, Massachusetts Pharmacies
  • Aug 20, 2021
    OPDP Issues Untitled Letter Over Alleged Lack of Risk Information in Sponsored Links
  • More

Medical Devices

  • Dec 21, 2016
    Final Rule Sets Postmarketing Safety Reporting Mandates for Combination Products, Constituent Parts
  • Dec 19, 2016
    Dismissal of Suit Alleging That Device Firm Promoted Unnecessary Battery Replacements Is Affirmed
  • Dec 14, 2016
    FDA Issues Final Guidance on Public Notification of Postmarket ‘Emerging Signals’ About Devices
  • Dec 10, 2016
    Synthes Executive’s Four-Year HHS Exclusion for Conduct ‘Relating to Fraud’ Upheld by District Court
  • Dec 5, 2016
    DMQS To Add Three Clinical Image Quality Questions to Annual Facility Inspections
  • Nov 30, 2016
    Final Guidance on 510(k)s for Magnetic Resonance Diagnostic Devices Supersedes 1998 Recommendations
  • Nov 22, 2016
    FDA Postpones Release of Highly Anticipated Final Guidance on Regulating Laboratory-Developed Tests
  • Nov 16, 2016
    OIG To Scrutinize Device Cybersecurity, Network Compromise Responses, According to FY 2017 Work Plan
  • Nov 10, 2016
    Agency Finalizes Guidance on Manufacturers’ Medical Device Reporting Responsibilities
  • Nov 9, 2016
    Alleged Off-Label Promotion Results in Device Manufacturer’s Guilty Plea, $36 Million Settlement
  • More

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