On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of Excellence, a federally...more
On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule (the “Rule”) that enables adult consumers (18 years of age or older) with perceived mild to moderate hearing impairment to purchase certain...more
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
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
A recent nationwide recall of a series of non-Food and Drug Administration (FDA)-approved stem cell products that have infected at least 12 patients has raised serious questions concerning legal exposure to providers that use...more