Former Commissioner says FDA has money and mandate to accelerate use of RWE in drug approval process
Earlier this month, former FDA Commissioner, Scott Gottlieb, spoke about [...]
Acting FDA Commissioner, Dr. Sharpless, speaks at 2019 NORD Conference on Rare Diseases
Last week, the National Organization for Rare Disorders (NORD) held [...]
FDA to Provide Guidance Documents Relating to Patient Experience Data
As part of the 21st Century Cures Act, the FDA [...]
New UK Health Data Research Hubs
Although the UK is home to some of the world’s [...]
New GAO report analyzes how drug companies view FDA efforts to facilitate expanded access
A report released by US Government Accountability Office (GAO) claims [...]
New FDA Real World Evidence Guidance Document
The FDA recognizes the important role that Real World Evidence [...]
FDA’s Project Facilitate, proposed initiative aims to improve current expanded access framework
The FDA is planning to launch a new program later [...]
Gottlieb wants industry to embrace new R&D initiatives
Earlier this month, Scott Gottlieb, announced that he will be [...]
New FDA ‘Request to Connect’ portal goes live
Last week, the FDA launched its new ‘Request to Connect’ [...]
New infographics highlight success of Orphan Drug Act
The Orphan Drug Act (ODA), which was passed in 1983 to [...]