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Advertising & Promotion

  • Mar 26, 2020
    Saudi Survey Assesses DTC Advertising
  • Mar 17, 2020
    DOJ: Spine Device Maker Made Payments to Surgeons Through ‘Consulting’ Company To Hide Kickbacks
  • Mar 17, 2020
    FTC Hits Company Over Nondisclosure of Payments To Internet Influencers Touting Their Products
  • Mar 9, 2020
    OPDP Issues First Warning Letters of 2020
  • Mar 4, 2020
    Sanofi To Pay $11.85 Million To Resolve Allegations of Providing Kickbacks Through Co-Pay Fund
  • Mar 3, 2020
    Mallinckrodt Reaches Global Settlement in Opioid Litigation
  • Feb 24, 2020
    FTC Seeks Public Comment on Endorsement and Testimonial Guides
  • Feb 18, 2020
    Bill Introduced in House Requiring List Prices in Drug DTC Ads
  • Feb 11, 2020
    FDA Issues Draft Guidance on Biosimilar Promotion
  • Feb 10, 2020
    FDA Warning Letter Citing Purell Hand Sanitizer Claims Prompts Consumer Class Action Suits
  • More

Good Clinical Practice

  • Feb 26, 2020
    Federal Court Rules Nearly 10 Years of Trial Results Must Be Posted on ClinicalTrials.gov
  • Feb 20, 2020
    ACRP Launches Monitoring Training Program
  • Feb 10, 2020
    Federal Court Sides with FDA in Clinical Hold Decision
  • Feb 5, 2020
    Two State Legislatures Considering Bills Mandating Coverage of Routine Care Costs in Clinical Trials
  • Jan 29, 2020
    ICMJE Revises Author Disclosure Form
  • Jan 22, 2020
    Fla. Bill Allows Travel Reimbursement for Cancer Trial Subjects, Caregivers
  • Jan 20, 2020
    CDER Issues Warning Letter to Investigator for Failing To Follow Trial’s Investigational Plan
  • Jan 9, 2020
    NASEM Plans February Workshop on Ethical Issues in New Biomedical Research
  • Jan 8, 2020
    NLM Issues Request for Information To Aid Modernization of ClinicalTrials.gov
  • Jan 8, 2020
    Bill Introduced in House Would Require All Subjects in ALS Trials To Receive Drug
  • More

U.S. Food Labeling

  • Aug 16,2018
    Group Sues USDA Over Delay in Issuing BE Labeling Standard
  • Aug 6,2018
    Who Should Regulate Cell-Cultured Technology — USDA, FDA, Both?
  • Aug 1,2018
    FDA Indicates Early Plans for ‘Modernizing’ Food Labels, While Stakeholders Provide Their Input
  • Jul 25,2018
    FDA Is Considering Changes to Dairy Standards of Identity
  • Jul 23,2018
    FDA Seeks Input on Lab-Grown Meat
  • Jul 23,2018
    FSIS Will ‘Study’ Consumers
  • Jul 17,2018
    FDA Seeks Comments on Size of Calorie Labeling of Food in Vending Machines
  • Jul 11,2018
    Task Ahead for USDA: Read, Respond to Feedback on BE Disclosure Proposal
  • Jul 4,2018
    Groups Want FSIS to Amend ‘Product of U.S.A.’ Definition for Meat
  • Jun 20,2018
    FDA Proposes To Add NDCs to ‘Dietary Fiber’ Definition
  • More

FDA Regulation & Enforcement

  • Nov 22, 2023
    Balance of Nature Supplements Maker, Distributor Resolve DOJ Allegations Through Consent Decrees
  • Nov 20, 2023
    FDA Issues Final Rule on Major Statement in DTC Drug Ads
  • Nov 17, 2023
    FTC Sends Warning Letters Regarding Lack of Disclosure in Social Media Posts
  • Nov 16, 2023
    Company Is Barred From Marketing Unapproved Contraceptive Cream Under Terms of Consent Decree
  • Nov 13, 2023
    Court: Novo Nordisk’s Unfair Trade Practices Suit Against Drug Compounder Is Preempted by FD&C Act
  • Nov 13, 2023
    OPDP Issues Two Untitled Letters Alleging False or Misleading Claims in DTC Materials
  • Nov 8, 2023
    New General Compliance Program Guidance Launches Guideline Modernization Initiative by HHS OIG
  • Nov 6, 2023
    CFSAN Updates Its Online Submission Module
  • Nov 2, 2023
    OIG: Offering Free Hearing Aid With Cochlear Implant Device Could Result in Anti-Kickback Sanctions
  • Oct 31, 2023
    FDA Issues Revised Draft Guidance on Providing Scientific Information on Unapproved Uses
  • More

Medical Devices

  • May 20, 2021
    FDA Gives Device Companies Two More Years To Remove NHRIC, NDC Numbers from Their Products
  • May 13, 2021
    Court: All but One Claim Brought Against ICD Manufacturer Are Preempted or Inadequately Pleaded
  • May 5, 2021
    FDA Amends Classification Regulations To Conform with Medical Software Provisions of Cures Act
  • Apr 29, 2021
    HHS, FDA Withdraw Trump Administration’s Proposal To Exempt 84 Device Types from 510(k) Mandates
  • Apr 22, 2021
    D.C. Circuit: FDA Lacks Broad Discretion To Choose To Regulate a Product as Either a Drug or a Device
  • Apr 20, 2021
    Study Finds Device Company Payments to Physicians Are Larger Than Drug Company Payments
  • Apr 14, 2021
    FDA Releases Initial List of Laboratories That Can Certify Conformance with Device Consensus Standards
  • Apr 8, 2021
    Ninth Circuit Allows Fraud-on-the-FDA Claim in False Claims Act Suit Brought Against Medtronic
  • Mar 31, 2021
    COVID-19 Emergency Sparks Increased Use of Bogus Device Registration Certificates, Agency Says
  • Mar 31, 2021
    Boston Scientific Settles with States Over Marketing of Surgical Mesh Devices
  • More

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