On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.
Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers

Amy Leiser
Amy advises medical technology and life science companies bringing novel device, digital health and diagnostic solutions to market. She specializes in providing practical advice consistent with the Food, Drug & Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), and related state laws to support clients in developing their regulatory and commercial strategies.
Amy counsels clients throughout the product and service lifecycle, from research and development through applicable regulatory authorizations and postmarket compliance. She also frequently supports cross-industry collaborations among pharmaceutical, biotechnology, medical device, clinical laboratory, and traditional technology companies.
Additionally, Amy has supported the day-to-day legal operations of device clients through in-house secondments during periods of transition or particularly high demand on their legal resources.
Amy was named a Rising Star in Food and Drug Law by Washington DC Super Lawyers for 2019-2020 and by Northern California Super Lawyers for 2022-2025. She speaks regularly at conferences on the regulation of devices and diagnostics.