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2023: Another Year Chock Full of Challenges for FDA
December 20, 2023 | Blog | By Joanne Hawana, Benjamin Zegarelli
In 2023, the FDA navigated challenges while achieving significant public health milestones. Member Joanne Hawana and Of Counsel Benjamin Zegarelli highlight key takeaways from the year, addressing multifaceted issues such as CBD regulation, the overhaul of in vitro clinical tests, and the management of manufacturing failures. These pivotal topics underscore the FDA’s proactive approach to evolving healthcare regulations and technological advancements.
FDA’s Digital Health High Notes from 2022
February 13, 2023 | Blog | By Benjamin Zegarelli
There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
Webinar Recording: FDA in 2021: A Look Ahead
February 18, 2021 | Webinar | By Joanne Hawana, Anthony DeMaio
FDA in 2020: What a Year! (Part 3 of 3)
December 23, 2020 | Blog | By Joanne Hawana
FDA in 2020: What a Year! (Part 2 of 3)
December 22, 2020 | Blog | By Joanne Hawana
FDA in 2020: What a Year!
December 15, 2020 | Blog | By Benjamin Zegarelli
Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA
December 19, 2019 | Blog | By Joanne Hawana
Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020
December 13, 2019 | Blog | By Joanne Hawana
Evolution & Revolution: Device Policy Priorities at FDA in 2019
December 5, 2019 | Blog | By Joanne Hawana, Benjamin Zegarelli
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