On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable
Continue Reading 3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act

A.J. Carvalho
A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance issues. He has assisted clients on myriad matters, including in complying with FDA regulations, responding to FDA enforcement actions and Congressional inquiries, conducting due diligence of FDA-regulated companies, and resolving issues that arise during product development.
Prior to joining the Food, Drug, and Device practice group, A.J. was a member of the Patent Litigation and White Collar Defense and Investigation Practice Groups. As a member of the Patent Litigation Practice Group, A.J. focused on representing pioneer pharmaceutical and biotechnology companies in Hatch-Waxman patent litigation. As a member of the White Collar Defense and Investigations Practice Group, A.J. focused on helping medical device, pharmaceutical, and biotechnology companies navigate civil and criminal investigations by the Department of Justice and FDA.
Prior to joining Covington, A.J. was a clinical research coordinator at Walter Reed National Military Medical Center focused on exploratory clinical research related to blast injuries (including amputations), advanced prosthetics (including myoelectric prosthetic control), and other concomitant conditions. His research and work has been published in numerous scientific peer-reviewed journals.
FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials
Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials. DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study…
Continue Reading FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials