FDA launches new data-sharing app called CURE ID
The FDA, in collaboration with the NIH’s National Center for [...]
WEP Clinical donates food to the Food Bank of Central & Eastern North Carolina
As part of our continued efforts to give back [...]
Project Orbis: new collaborative program allows for concurrent drug approvals in participating countries
Earlier this year, the FDA announced the launch of Project [...]
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 [...]