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Advertising & Promotion

  • Jun 17, 2017
    Company Issues Corrective Statement for Patient Leaflet after PMCPA Case
  • Jun 16, 2017
    Astellas U.K. Slammed by PMCPA for Lack of Oversight for Patient Support Programs
  • Jun 15, 2017
    AMA Calls for Putting Prices in DTC Ads
  • Jun 13, 2017
    FDA To Examine Use of Disclosures in Drug Ads
  • Jun 9, 2017
    More N.Y. Counties File Lawsuits Against Opioid Manufacturers
  • Jun 9, 2017
    OPDP Researchers Will Examine ‘Adequate Provision’ for Brief Summaries in DTC Broadcast Ads
  • Jun 7, 2017
    Group Pushes State Laws Allowing Off-Label Promotion
  • Jun 7, 2017
    Nevada Gov. Vetoes Bill Requiring Sales Rep. Reporting; New Bill Passed
  • Jun 5, 2017
    Nevada Gov. Considers Bill Requiring Sales Rep Reporting
  • Jun 1, 2017
    Ohio Files Lawsuit Against Five Manufacturers Over Opioid Marketing
  • More

Good Clinical Practice

  • Dec 7, 2017
    Study Finds Trial Transparency High
  • Dec 5, 2017
    PhRMA-EFPIA Survey Finds Companies Striving To Meet Data Sharing Principles
  • Dec 5, 2017
    EMA Issues Paper on Using Extrapolation for Development of Pediatric Medicines
  • Dec 3, 2017
    FDA Plans Adaptive Trial Design Meeting March 20
  • Dec 3, 2017
    UK Needs Deal on Clinical Research Issues Before Leaving EU
  • Nov 30, 2017
    CDRH Issues Draft Guidance to Aid Study Designs for In Vitro Diagnostic Device Dual Submissions
  • Nov 27, 2017
    Fox Foundation and 23andMe Collaborate
  • Nov 27, 2017
    EMA Upgrades EudraVigilance System
  • Nov 27, 2017
    FDA Plans Workshop on IND Safety Reporting
  • Nov 21, 2017
    Walden Questions NIH Further on Emergency Medical Research without Informed Consent
  • More

U.S. Food Labeling

  • Jan 31,2012
    Tropicana Sued over '100% Pure and Natural' Claim
  • Dec 31,2011
    Study Finds Consumers Have Limited Attention Span When It Comes to Nutrition Facts Panel
  • Dec 31,2011
    Oregon Man Pleads Guilty To Selling Corn Falsely Labeled as Organically Grown
  • Dec 31,2011
    Product Recalls
  • Dec 31,2011
    FSIS Issues Proposed Rule to Streamline Labeling Approval for Meat and Poultry Products
  • Dec 31,2011
    FTC Takes Enforcement Action Against Marketer Making Deceptive Weight-Loss Claims
  • Dec 31,2011
    FDA Warning Letter Targets 'All Natural' Claim
  • Dec 31,2011
    FTC Wins Court Case Involving Substantiation
  • Nov 30,2011
    Study Finds Growing Majority of U.S. Families Buying Organic Foods in 2011
  • Nov 30,2011
    FSIS Revises Definitions of Five Poultry Classes
  • More

FDA Regulation & Enforcement

  • Jun 4, 2020
    Court Imposes Permanent Injunction on Operators of Herbal Products Store for Violating FDA Mandates
  • Jun 2, 2020
    BMJ Analysis Finds That Most Medical Association Leaders Have Financial Ties to Industry
  • May 28, 2020
    FDA Offers Food Manufacturers, Vending Machine Operators Additional Temporary Labeling Flexibilities in Response to COVID-19
  • May 27, 2020
    Appeals Court Affirms Dismissal of Device Manufacturing Defect Claim on Preemption Grounds
  • May 21, 2020
    OPDP’s Bad Ad Program To Add Case Studies
  • May 13, 2020
    AdvaMed Offers New Compliance Guidance for Device Companies’ Response to COVID-19 Emergency
  • May 13, 2020
    AMS Extends Sunset Date of Various Substances on Organic Substances List
  • May 12, 2020
    J&J Reaches $3.9 Million Settlement with West Virginia over Marketing of Surgical Mesh Products, Hip Replacement Devices
  • May 12, 2020
    Court Imposes Order of Permanent Injunction on Hand Sanitizer Manufacturer That Defied FDA Mandates
  • May 7, 2020
    Blue Bell Creameries L.P. To Plead Guilty, Pay $19.35 Million for Contamination of Ice Cream in 2015
  • More

Medical Devices

  • Aug 27, 2014
    Federal Appeals Court Rejects Supplier’s Challenge to Medicare DMEPOS Competitive Bidding Program
  • Aug 15, 2014
    Agency Launches Pilot Program for Medical Device Development Tools
  • Aug 13, 2014
    FDA Revises Draft Guidance on De Novo Classification Procedure
  • Aug 6, 2014
    Citing MDUFA III Commitment, FDA Announces Intent To Exempt a Range of Devices From 510(k) Mandates
  • Aug 6, 2014
    Q&A Guidance on Section 517A Appeals Finalized by CDRH
  • Aug 6, 2014
    Most Medical Device User Fee Rates Will Be Reduced Slightly for FY 2015
  • Aug 5, 2014
    FDA Issues Guidance on Companion Diagnostics
  • Aug 5, 2014
    Draft Framework Would Increase FDA's Laboratory-Developed Test Oversight
  • Jul 31, 2014
    Finalized Substantial Equivalence Guidance Drops Discussions of Special and Abbreviated 510(k)s
  • Jul 17, 2014
    SEC Issues Subpoena to Biomet; Company Raises Possibility That FCPA Settlement Was Violated
  • More

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