Simplifying Global Compliance
Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/Transcript
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Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies: DAIA Will be a Game-Changer
In August 2018, the FDA provided feedback on a draft of the Diagnostic Accuracy Innovation Act (DAIA), which Representatives Larry Bucshon and Diana DeGette publically released last year.
If passed in the next session of Congress, the current draft of the DAIA will impact FDA regulation of laboratory developed tests (LDTs), in vitro companion diagnostic devices, and targeted drug and biologic therapies. DAIA provides a predictable and timely path to market for these important clinical tests. Will it pass next year? Hill insiders say yes. Why? Because for the first time ever, FDA and Congress agree on its key elements.
And really, when does that happen in Washington these days?
Based on industry reaction — and Congress’ expressed eagerness to resolve this issue — it’s likely that next year this legislation, in one form or another, will significantly change the regulations of LDTs, companion diagnostics and targeted therapies.
It’s not too late to influence the final form of this legislation, and it’s definitely not too soon to start preparing for the future. If you’re in LDT space, and you want your legislators in the next Congress and FDA to know what you think about the current plan, this is your best chance to make your voice known.
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. You’ll learn the following:
- Current regulatory landscape for LDTs and in vitro companion diagnostics
- Breakdown of the DAIA — how the legislation would change FDA’s oversight of in vitro diagnostic products, and would affect pre-and post-market requirements
- How the DAIA defines low-risk and high-risk test and how it affects your regulatory burden
- Under what circumstances an existing product will need to seek marketing approval from FDA
- What enforcement powers will FDA be granted — such as the ability to demand a product recall
- The implications for targeted drug and biologic therapies — such as when an in vitro companion diagnostic must be approved by FDA before it will approve the targeted therapy
Order today to understand what you should be doing to prepare for these coming changes, including identifying products that may fall under DAIA and planning to obtain the data needed to support a marketing application.
Quality and regulatory professionals in drugs, biologics, lab testing, companion diagnostics, and gene therapies.
Meet Your Presenters
Mike Druckman, Partner, Hogan Lovells US LLP
Mike Druckman is a partner in the FDA pharmaceutical group at Hogan Lovells US LLP. He previously served as Associate Chief Counsel for Biologics and for Enforcement at FDA. He works closely with lawyers in the firm’s FDA medical device group in advising clients who are developing targeted therapies, including gene therapies, on designing their clinical programs appropriately to accommodate diagnostics.
Blake Wilson, Senior Associate, Hogan Lovells US LLP
Blake Wilson is a senior associate in the FDA medical device group at Hogan Lovells US LLP. Blake’s practice focuses on premarket approval of medical devices, and he regularly advises on LDTs.
