ISPOR Comments on Health Policies

ISPOR COMMENTS ON HEALTHCARE POLICIES

• ISPOR Comments on US Comparative Effectiveness Program (April 2008)

• FDA Use of Medication Guides to Distribute Drug Risk Information to Patients (July 2007)

» FDA: Use of Medication Guides to Distribute Drug Risk Information to Patients
» Notice of Public Hearing; Request for Comments on FDA website

ISPOR COMMENTS ON RESEARCH POLICIES

• ISPOR Comments on EUnetHTA Core Model for Diagnostics (December 2008)
  
  
  • » EUnetHTA Core Model for Diagnostic Technologies (July 15, 2008)
    
    
• ISPOR Comments on EUnetHTA draft HTA Core Model for Medical and Surgical Interventions (October 2007)
  
  
  • » EUnetHTA HTA Core Model
  • » EUnetHTA
   
• Proposed US Medicare Ruling on Use of Drug Claims Information for Outcomes Research (December 2006)
  
  
» Proposed US Medicare Ruling on Use of Drug Claims Information for Outcomes Research (December 2006)
» ISPOR Comments available at CMS website
- Electronic Comments on CMS Regulations please see CMS-4119-P57 on pages 26-36


• Journal of American Medical Association (JAMA) Publication Policy on Data Access and Responsibility (June 2006)
  
  

  » JAMA Policy on Data Access and Responsibility (June 2006)
  » JAMA Responds to ISPOR's Comments on Data Access and Responsibility

• FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (April 2006)
  
  

  » FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (December 2009)
  » FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims – DRAFT GUIDANCE (February 2006)
  » EMEA HRQL Guidance (July 2005)

• Guidance for Factors CMS Considers in Making Determination of Coverage with Evidence Development (June 2005)

» Guidance for Factors CMS Considers in Making Determination of Coverage with Evidence Development (June 2005)


• Medicare RX Data Elements (February 2005)
  
   
• FDA Risk Management Concept Paper (April 2003)

  » FDA Risk Management Concept Paper (April 2003)
  » FDA Risk Management Workshop announcement

• FDA Guidance for the Industry - Promotional Use of Health Care Economic Information (June 1998)

  » FDA draft Guidance on Economic Information for Promotional Use
  » FDAMA Section 114 Debriefing Conference