Steven J. Gonzalez from Hyman, Phelps, & McNamara Author Profile Page

Steven J. Gonzalez

Hyman, Phelps, & McNamara

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United States
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Compliance Food, Drugs, Healthcare, Life Sciences

Keeping Your Company's Federal Contracting Options Safe In The Face Of Pending BIOSECURE Act Legislation

11 Mar 2024 | United States

FDA Phones A Friend: Joint Statement With CMS Eschews CLIA Modernization And Supports FDA Oversight Of LDTs

13 Feb 2024 | United States

FDA Can't Reclassify Its Way Out Of Reviewing 100,000 LDT Submissions

12 Feb 2024 | United States

Outlining The Legal Arguments Against FDA's Proposed Rule Regulating LDTs

05 Feb 2024 | United States

Conference Notebook: Reporting From FDLI's 2023 Enforcement, Compliance, And Litigation Conference

13 Dec 2023 | United States

A Question 30 Years In The Making: Would A Final LDT Rule Withstand Judicial Scrutiny?

07 Nov 2023 | United States

AI/ML-enabled Medical Devices Have Everyone's Attention, Including FDA's

25 Oct 2023 | United States

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