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Advertising & Promotion

  • Oct 18, 2018
    FDA Releases Draft Guidance on Presentation of Efficacy and Risk Information in DTC Labeling and Ads
  • Oct 15, 2018
    Federal Trade Commission Is Reviewing Violation Remedies
  • Oct 15, 2018
    Pfizer Settles with N.Y over Coupons
  • Oct 8, 2018
    FDA’s Changing Policy on Advertising and Promotion Enforcement Becomes Clearer
  • Oct 4, 2018
    GSK Revises Policy on Payments to Physicians
  • Sep 28, 2018
    Opioids Bill Expands Open Payments Reach
  • Sep 27, 2018
    Dietary Supplements Lead the Way for NAD Cases
  • Sep 24, 2018
    FTC Charges Company Made Unsupported Health Claims for Intravenously Injected Therapy Products
  • Sep 19, 2018
    California Files Insurance Fraud Complaint Against AbbVie Over Home Nurse Program
  • Sep 19, 2018
    Company to Pay $20 Million To Settle SEC Complaint Over Misleading Investors
  • More

Good Clinical Practice

  • Dec 17, 2018
    NHC Developing Fair Payment Calculator for Patient Advice on Product Development
  • Dec 15, 2018
    NIH Working Group Issues Recommendations on Relationships with Foreign Researchers
  • Dec 13, 2018
    HHS Sued Over Failure To Provide Public Notices of Sponsors' Failures To Post Results on ClinicalTrials.gov
  • Dec 11, 2018
    District Court Dismisses Lawsuit over Non-disclosure of Trial Results
  • Dec 7, 2018
    Bill To Create Trials Working Group Approved by N.J. Assembly Committee
  • Dec 7, 2018
    FDA Plans Guidance for Use of RWE in Trials
  • Dec 6, 2018
    Analysis Finds Trial Terminations Mostly Caused by Low Subject Enrollment
  • Dec 6, 2018
    EPA Proposes Revisions To Subject Protection Rules
  • Dec 3, 2018
    EMA Issues Opinion on eSource DDC
  • Dec 3, 2018
    Florida Bill Introduced Allowing Access To Investigational Stem Cell Treatments
  • More

U.S. Food Labeling

  • Jan 21,2015
    USDA ‘Report’ on Federal Honey Standard Merely Summarizes Public Comments
  • Jan 21,2015
    Study Suggests Nutrition Facts Panel Ineffective in Guiding Consumers Toward Healthy Foods
  • Jan 20,2015
    Updated Guidance on Blended Fish Labeling To Limit Enforcement
  • Jan 20,2015
    Congressmen Push Mandatory Labeling Bill for GMO Fish in New Legislative Session
  • Jan 15,2015
    District Court Grants Summary Judgment in Egg Labeling Suit Against FDA
  • Jan 8,2015
    FSIS To Impose Disclosure Requirements on Meat Processors Engaged in ‘Plumping’
  • Dec 22,2014
    USDA Plans to Overhaul Nutrition Facts Panel for Meat, Poultry Products
  • Dec 18,2014
    Ore. Election Results Verify Narrow Loss for GMO Labeling Advocates
  • Dec 11,2014
    Oregon GMO Proponents Concede Defeat as Recount Draws to Close
  • Dec 11,2014
    FDA Sets Uniform Compliance Policy Date for Future Food Labeling Rules
  • More

FDA Regulation & Enforcement

  • Jan 28, 2022
    OPDP Issues First Untitled Letter of 2022
  • Jan 27, 2022
    Fourth Circuit Affirms Dismissal of False Claims Allegations that Drug Maker Misreported Best Prices
  • Jan 26, 2022
    State AGs Seek To Limit Effect of Preemption Provision in FDA’s Proposed Rule on OTC Hearing Aids
  • Jan 21, 2022
    Bill To Remove DTC Prescription Drug Advertising Deduction Introduced in US House
  • Jan 20, 2022
    First Circuit Asks Mass. High Court If There Is a State Law Duty To Report Adverse Events to the FDA
  • Jan 20, 2022
    Insys Founder Kapoor Urges Supreme Court To Consider Issue of Nonphysician Liability Under CSA
  • Jan 18, 2022
    FDA Allows Health Claim for Magnesium and Risk of Hypertension, Revokes Identity Standard for French Dressing
  • Jan 14, 2022
    OPDP Reminds Companies in Untitled Letter That Complete Promotions Must Be Submitted
  • Jan 12, 2022
    Clinical Trial Site Co-Owner Pleads Guilty to Obstructing FDA Inspection by Falsely Attesting to Data
  • Jan 7, 2022
    OPDP Adds New Division
  • More

Medical Devices

  • Sep 19, 2017
    Draft Guidance from CDRH on Microneedling Devices Recommends Use of De Novo Classification Pathway
  • Sep 13, 2017
    CDRH Explores Streamlined Review of PMA Applications with Emphasis on Device Quality
  • Sep 12, 2017
    FDA Wants Ethnic and Racial Demographic Data Captured in Two Distinct Categories
  • Sep 6, 2017
    Final Guidance on Interoperable Devices Urges Transparency, Use of Consensus Standards
  • Sep 5, 2017
    FDA Finalizes Guidance on Use of Real-World Evidence When Making Regulatory Decisions About Devices
  • Aug 29, 2017
    Major Increases Set for Device User Fee Rates in FY 2018; De Novos Will Be Subject to Fees
  • Aug 23, 2017
    FDA User Fee Legislation Establishes Risk-Based Scheduling of Device Establishment Inspections
  • Aug 16, 2017
    Regulatory Agenda Includes Action This Year on De Novo Classifications, Clinical Data Acceptance
  • Aug 15, 2017
    First Circuit Reverses Dismissal of False Claims Allegations Based on ‘One Actual Sale’ of Device
  • Aug 14, 2017
    Final Rule on FDA Acceptance of Data from Device Studies Expected in December
  • More

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