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About

Audrey Mercer is an associate who specializes in the life sciences and healthcare industries and works out of the firm’s Dallas office.

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What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

June 18, 2025
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LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

April 7, 2025
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Finally, FDA’s Final Word on Unapproved Use Communications

February 7, 2025
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FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

January 27, 2025
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FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

January 14, 2025
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New Accelerated Approval Guidance Underscores Need for Accountability

December 19, 2024
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LDT Final Rule Series: Part 3 – Legal Challenges

December 16, 2024
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FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

December 5, 2024
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LDT Final Rule Series: Part 2 – Response to the Rule

June 6, 2024
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LDT Final Rule Series: Part 1 – Rule Overview

April 30, 2024

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About

Audrey Mercer is an associate who specializes in the life sciences and healthcare industries and works out of the firm’s Dallas office.

Connect: https://www.sheppardmullin.com/amercerEmail
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Audrey Mercer

Connect: https://www.sheppardmullin.com/amercerEmail
Subscribe: Subscribe via RSS
Blogs
  • Government Contracts & Investigations Blog
  • Healthcare Law Blog
Firm/Org
  • Sheppard, Mullin, Richter & Hampton LLP
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