The Honorable Stephen Hahn Commissioner U.S. Food and Drug Administration Food and Drug Administration Dear Commissioner Hahn: On behalf of the National Health Council (NHC), I am pleased to provide the following comments […]
FDA regulations
NHC Commitment to Ensure Representativeness in all Policy Work
By Maddie Mason, Senior Associate, Policy The National Health Council (NHC) has pledged to ensure that our policy work is inclusive and representative of all populations. In our comment and policymaking opportunities, we are particularly committed to this, and strive to have our policy work directly reflect […]
NHC Comments on PDUFA VII Public Stakeholder Meeting
By Maddie Mason, Senior Associate, Policy The National Health Council (NHC) submitted comments last week to the Food and Drug Administration (FDA) on their July 23 Public Stakeholder Meeting on the Prescription Drug User Fee Act (PDUFA) VII where NHC […]
Reauthorization of the Prescription Drug User Fee Act
The National Health Council (NHC) appreciates the opportunity to provide a response to the Food and Drug Administration’s (FDA’s) request for comments on the next cycle of the Prescription Drug […]
2020 National Health Council Policy Matrix
By Maddie Mason, Senior Associate, Policy Each year the National Health Council’s (NHC’s) Board Policy Committee develops a Policy Matrix that is intended to serve as a road map for […]
Patient-Focused Medical Product Development Webinar Series
Patient-Focused Medical Product Development Webinar Series The NHC’s Patient-Focused Medical Product Development series builds upon our Clinical Outcome Assessment (COA) series, which we hosted between Nov. 2018-Dec. 2019. The series […]
Webinar: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance
Webinar: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance The National Health Council and our member organizations present a webinar on the FDA’s second draft guidance in their series […]
2019 Washington Representatives Retreat
2019 Washington Representatives Retreat Each year, the National Health Council (NHC) hosts the Washington Representatives Retreat, a two-day event to gather staff from NHC member organizations to address strategic, operational, and […]
Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration
Dr. Eleanor Perfetto, NHC Executive Vice President, Strategic Initiatives, co-authored a paper titled, “Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration,” which was published […]
The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence
The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence This webinar provided an overview of Sentinel’s growing capabilities and value in regulatory […]