Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more
4/8/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health ,
Relief Measures ,
Supply Chain
With the “patient experience” becoming an increasingly important element in directing not only where industry spends its limited drug development resources but how clinical trials are designed, the U.S. Food and Drug...more
This client alert provides background on two recent developments related to patient access to investigational therapies outside of the clinical trial setting: expanded access and right-to-try. First, we discuss a fairly new...more