On January 17, Mintz’s Bethany Hills moderated a panel discussion at the New York State Bar Association’s Food, Drug & Cosmetic Law Annual Meeting entitled, “Hot Topics in Devices: LDT and Digital Health.” Ms. Hills was joined by Aaron Josephson, a Senior Director of ML Strategies, a wholly-owned consulting subsidiary of Mintz; Lesley Maloney of PharmD.Roche; and Howard Zucker, M.D., JD, the Commissioner of Health for New York State. The esteemed group explored:
- Insights on the new Verifying Accurate Leading-edge IVCT Development (VALID) Ac and FDA’s 2018 “technical assistance” to Congress on the Diagnostic Accuracy and Innovation Act (DAIA) that is shaping VALID moving forward.
- How New York State leads in diagnostic test oversight and its relationship with the FDA.
- FDA’s evolving approach to digital health technologies, including recent announcements about the Pre-Cert program.
- Risks and opportunities of the FDA’s proposed regulatory model.
As Chair of Mintz’s FDA practice, Ms. Hills leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic life science and health technology companies enter and navigate the U.S. health care market. She advises life science companies and investors in a broad range of regulatory, reimbursement, and U.S. and international compliance matters.
Mr. Josephson recently joined in September. Earlier, he was a senior policy advisor at FDA’s Center for Devices and Radiological Health (CDRH) where he worked on projects involving regulatory policy, strategic planning, communications, and budget. He was the primary CDRH representative in discussions with Congress and industry about the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act (FDARA). Mr. Josephson also served on the FDA team that negotiated the reauthorization of the medical device user fee program (MDUFA 4). Prior to joining CDRH, he worked at FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
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