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Archives for: November 19th, 2018

Leveraging Real-World Treatment Experience from Expanded Access Protocols

Written by Christina Jensen on November 19, 2018

Building on the Reagan-Udall Foundation for the FDA’s work with FDA and other stakeholders to develop the Expanded Access Navigator, the Reagan-Udall Foundation is convening stakeholders from government, industry, academia and patient groups to discuss process issues that include:

  • Increase understanding of the expanded access program
    • Identify and discuss strengths, challenges… Read More

Updated Study Analyzes Use and Cost of Orphan Drugs

Written by Laura Mullen on October 18, 2018

Washington, D.C., October 18, 2018— Despite a record-breaking number of new approvals, orphan drugs remain a nominal part of overall drug spending, accounting for only 9.6% of total sales in the U.S. in 2017, according to a new study released today by the IQVIA Institute. The study… Read More

Public Meeting on Patient-Focused Drug Development for Chronic Pain

Written by Christina Jensen on July 9, 2018

On July 9, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Chronic Pain. FDA is interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who… Read More

NORD Issues Statement on Recent CMS Actions Pertaining to Patient Access Within Medicaid Formularies

Written by Christina Jensen on June 27, 2018
Washington, D.C., June 27, 2018 – The National Organization for Rare Disorders (NORD), the leading independent nonprofit organization representing the 30 million Americans with rare diseases, released the following statement regarding this week’s actions by the Centers for Medicare and Medicaid Services (CMS) to protect patient access to medication… Read More