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Advertising & Promotion

  • Jun 6, 2019
    Insys Agrees to $225 Million Global Resolution of Allegations of Illegal Promotion of Subsys
  • Jun 6, 2019
    Insys CIA Includes Novel Provisions
  • Jun 5, 2019
    OPDP Issues Second Untitled Letter for 2019
  • Jun 4, 2019
    Major Statement Rule Pushed to 2020
  • Jun 4, 2019
    Almirall Pays Feds, California $6.6 Million To Resolve Kickback Allegations
  • Jun 4, 2019
    Three More States, D.C. Sue Purdue Pharma
  • May 20, 2019
    Jury Finds for Allergan in False Advertising Case
  • May 18, 2019
    Five More States Sue Purdue Pharma
  • May 17, 2019
    Facial Implant Maker Sent Warning Letter Over Marketing Product for Lips
  • May 15, 2019
    Pennsylvania Sues Purdue Pharma Over Alleged Illegal Marketing
  • More

Good Clinical Practice

  • Jul 15, 2019
    FDA Issues Draft Guidance on Development of Hormonal Drugs To Prevent Pregnancy
  • Jul 14, 2019
    Viewpoint Contends Researchers Must Better Protect Pregnant Women and Neonates in Opioid Studies
  • Jul 14, 2019
    FDA Revises 20-year-old Guidance on Population Pharmacokinetics
  • Jul 11, 2019
    Elements To Include in Live Case Presentation Request
  • Jul 11, 2019
    FDA Issues Final Guidance on ‘Live Case’ Presentations in Device Trials
  • Jul 10, 2019
    Pa. Hospital Receives CBER Warning Letter Over IRB Meeting Minutes
  • Jul 5, 2019
    Federal Case Over Subject Death Continues
  • Jul 3, 2019
    European Agencies Remind Sponsors To Report Trial Results
  • Jul 3, 2019
    Following Trend, Court Holds That Calling Soda ‘Diet’ Does Not Promise Weight Loss
  • Jul 1, 2019
    Survey Finds Research Enterprise Slowly Moving To Unified Operating Systems
  • More

U.S. Food Labeling

  • Jan 11,2017
    Guidance Issued on Certificate Requirement for Organics Imported From Mexico
  • Dec 31,2016
    FDA Extends Comment Period on Use of 'Healthy' Claim
  • Dec 21,2016
    FSIS Urges Food Makers To Switch to ‘Best if Used By’ Date Label
  • Dec 18,2016
    FDA to Align Menu Labeling Compliance and Enforcement Dates
  • Dec 14,2016
    Draft Guidance Issued on Use of Fruit, Vegetable Juice for Color
  • Dec 14,2016
    FDA Makes Public Adverse Event Data for Foods and Cosmetics
  • Dec 2,2016
    USDA Issues Proposed Labeling Changes for Meat and Poultry
  • Nov 30,2016
    Standards Board Votes To Exclude Next Generation GE Ingredients
  • Nov 18,2016
    FSIS To Allow Meat and Poultry Producers To Use New FDA Nutrition Facts Label Temporarily
  • Nov 17,2016
    Allergen Labels May Be Doing More Harm than Good, Study Finds
  • More

FDA Regulation & Enforcement

  • Jan 6, 2023
    Arizona Sues Drug Maker Over Potency Statements
  • Jan 5, 2023
    Jet Medical Resolves DOJ Allegations That It Marketed Device Without FDA Approval or Clearance
  • Jan 5, 2023
    FDA, FSIS Set Food Labeling Uniform Compliance Date
  • Jan 5, 2023
    FDA Removes Stay on Yogurt Standard of Identity Provisions
  • Jan 4, 2023
    HHS OIG Greenlights Drug Firm’s Plan To Provide Free Trial Units of Injectable Antipsychotic to Hospitals
  • Dec 30, 2022
    FTC Expands Advertising Guide To Include All Health-Related Claims
  • Dec 23, 2022
    Florida Supreme Court Considers Grand Jury Investigation of Manufacturers’ COVID-19 Vaccine Claims
  • Dec 22, 2022
    Device Firm To Pay Over $12 Million To Resolve Claims Related to Alleged Misrepresentations to FDA
  • Dec 22, 2022
    Consent Decree Shuts Down Outsourcing Facility’s Operations After Years of Alleged cGMP Violations
  • Dec 22, 2022
    Agencies Jointly Issue RFI for Input on Regulating Biotechnology
  • More

Medical Devices

  • Sep 12, 2019
    Final Guidance on FDA’s Acceptance Review of De Novo Device Classification Requests Is Issued
  • Sep 4, 2019
    Finalized Guidance Shows How FDA Deals with Uncertainty About Medical Devices’ Benefits and Risks
  • Aug 29, 2019
    Preemption, Insufficient Pleading Doom Patients’ Suits Against Silicone Breast Implant Manufacturer
  • Aug 22, 2019
    Device Maker Agrees To Pay $3.3 Million in False Claims Settlement Stemming from Trade Allegations
  • Aug 15, 2019
    Court: Arizona Statute Blocks Award of Punitive Damages Against Maker of Device with 510(k) Clearance
  • Aug 6, 2019
    CDRH Draft Guidance Identifies Testing, Labeling Appropriate for Devices Intended for MR Environment
  • Jul 30, 2019
    FDA Announces Larger Device User Fee Rate Increases for FY 2020, 7.21 Percent Registration Fee Hike
  • Jul 25, 2019
    Final Combination Product Postmarketing Safety Reporting Guidance Details Applicants’ Obligations
  • Jul 17, 2019
    FDA Issues Innovation Challenges To Address Concerns with Ethylene Oxide Sterilization of Devices
  • Jul 10, 2019
    Senators Question ‘Progressive Approval’ Proposal for Devices Included in FDA’s FY 2020 Budget Request
  • More

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