The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more
The COVID-19 pandemic presents ongoing challenges to the pharmaceutical and biologics industries, where in-person inspection of facilities is often required for FDA approval of applications to market drug or biological...more
On April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s...more