As the COVID-19 pandemic progressed, the U.S. Food and Drug Administration (FDA) sought to provide timely guidance to the relevant stakeholders to support continuity and response efforts. Notwithstanding, on August 19, 2020,...more
Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more
The U.S. Food and Drug Administration (FDA) has faced many operational challenges during the COVID-19 pandemic. Early on, the FDA temporarily postponed routine surveillance facility inspections, conducting mission-critical...more
2020 was an historical year in the health care industry with the global COVID-19 pandemic being the most impactful issue for most of the year. As we enter 2021, we are tracking the following issues which will have an impact...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act. On April 24, 2020, the President signed into law the Paycheck Protection Program and Health Care Enhancement...more
Over the past several months, the United States Food and Drug Administration (FDA) has issued several guidance documents and guidelines to regulate the importation and distribution of respirators for medical purposes during...more