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
Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose...more
It was a largely encouraging week in the U.S. COVID-19 response, where the vaccination rollout continues to outpace initial goals. Elsewhere, the World Health Organization (WHO) weighed in on the idea of requiring...more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...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
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...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
What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more