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Advertising & Promotion

  • Mar 30, 2019
    New York Sues Six Drug Makers, Four Distributors and Sackler Family Over Opioid Marketing
  • Mar 30, 2019
    Illinois Bill Would Ban Physician ‘Gifts’
  • Mar 27, 2019
    Oklahoma-Purdue Reach $270 Million Settlement in State Opioid Case
  • Mar 27, 2019
    Local Entities Sue Sacklers Over Opioid Marketing
  • Mar 23, 2019
    District Court Dismisses Securities Fraud Case Involving Off-Label Marketing Concerns
  • Mar 23, 2019
    Montana Bill Examines Drug Price Transparency
  • Mar 23, 2019
    House Oversight Committee Requests Info on OxyContin Marketing
  • Mar 21, 2019
    Ill. House Approves Bill Prohibiting Sale of Prescribing Data for Marketing
  • Mar 21, 2019
    OMB Reviewing DTC List Price Rule
  • Mar 21, 2019
    OPDP Study Finds Extrinsic Cues Can Influence Consumer Choices
  • More

Good Clinical Practice

  • May 10, 2019
    ICH Releases Draft Revision of General Considerations for Clinical Studies
  • May 9, 2019
    FDA Provides Guidance on Topical OTC Maximal Usage Trial Studies
  • May 9, 2019
    FDA Issues Two Draft Guidances on Studies Examining Drug Effects on Pregnant and Nursing Women
  • May 4, 2019
    FDA Issues Draft Guidance on Trials for Pediatric and Adult ADHD Drugs
  • May 4, 2019
    Survey Finds Most EU Trials Violate Transparency Rules
  • May 2, 2019
    Texas Bill Extending Right-to-Try to Severe Chronic Diseases Passes House Panel
  • May 2, 2019
    FDA Plans August Workshop on Trial Designs for Antiviral Products
  • Apr 26, 2019
    NIH Issues Final Guidance on HGT Trials
  • Apr 25, 2019
    FDA Issues Draft Guidance on Analysis of Covariance in Randomized Clinical Trials
  • Apr 25, 2019
    California Senate Considers Bill Expanding Insurance Coverage of Routine Trial Costs
  • More

U.S. Food Labeling

  • May 26,2016
    New Rules Modernize Nutrition Facts Labels
  • May 25,2016
    Candies Recalled Over Allergen Labeling
  • May 24,2016
    Undeclared Milk Allergen Causes Recalls
  • May 17,2016
    FDA to Re-evaluate Definition of Healthy
  • May 17,2016
    WLF Prods FDA to Adopt National Policy on Use of ‘Natural’
  • May 17,2016
    FDA Issues Updated Guidance for Medical Foods
  • May 12,2016
    FDA Sets Deadline for Menu Labeling Compliance
  • May 4,2016
    Quaker Oats Sued Over ‘Natural’ Claims
  • Apr 25,2016
    Court Dismisses Complaint Alleging ‘0g Trans Fat’ Statement on Product Label Was Misleading
  • Apr 20,2016
    Undeclared Sulfites Leads to Two Recalls
  • More

FDA Regulation & Enforcement

  • Sep 28, 2022
    Biogen Settles False Claims Allegations for $900 Million; Relator To Receive Nearly $250 Million
  • Sep 25, 2022
    OPDP Researchers Plan Two New Studies
  • Sep 22, 2022
    DOJ Toughens Stance on Companies With Histories of Misconduct, Seeks To Encourage Self-Disclosure
  • Sep 18, 2022
    District Court Dismisses Novartis Speaker Program Suit
  • Sep 16, 2022
    District Court Upholds Majority of NBFDS Regulations But Rejects Text Message Disclosure Option
  • Sep 15, 2022
    Ninth Circuit: Manufacturer Cannot Sue To Stop Compounder From Producing Purported Copy of Drug
  • Sep 15, 2022
    Groups Want FDA To Beef Up Front-of-Package Nutrition Labeling Requirements
  • Sep 14, 2022
    Third Circuit Upholds Dismissal of Lanham Act Case
  • Sep 7, 2022
    Bayer Settles Lawsuits Over Allegations of Kickbacks and False Statements
  • Sep 7, 2022
    Respironics Settles Allegations That It Gave Prescribing Data to DME Suppliers To Induce Purchases
  • More

Medical Devices

  • Feb 20, 2019
    Draft Guidance Shows How To Request Nonbinding FDA Feedback Following a Device Establishment Inspection
  • Feb 14, 2019
    FDA Finalizes Guidance on Public Warnings, Notifications Following Recalls of Violative Products
  • Feb 13, 2019
    FDA Will Not Require 510(k) Submissions for Unclassified Devices Identified in New Guidance Document
  • Feb 5, 2019
    Finalized Guidance Presents FDA’s Commitments To Minimize Regulatory Burdens on Device Manufacturers
  • Jan 28, 2019
    FDA Calls for Comments on Proposal To Publicize List of 510(k) Devices That Rely on Older Predicate
  • Jan 23, 2019
    DePuy Reaches $120 Million Consent Judgment with States
  • Jan 22, 2019
    FDA Finalizes Guidance on 510(k) Pathway Through Which Performance Criteria Can Establish Substantial Equivalence
  • Jan 16, 2019
    Citing Federal Preemption, New Jersey Court Dismisses Claims Against Manufacturer of Breast Implant
  • Jan 15, 2019
    AdvaMed Updates Ethics Code on HCP Interactions
  • Jan 9, 2019
    FDA Takes Next Steps Toward Developing Precertification Pilot Program for Software Products
  • More

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