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Risk Assessment New Guidance Life Sciences

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] DOJ’s New Guidance on Evaluating Compliance Programs: What You Need to Know

In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department’s recent guidance on evaluation of corporate compliance programs. Among the topics covered: •...more

Knobbe Martens

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

Hogan Lovells

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader...

Hogan Lovells on

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more

Akin Gump Strauss Hauer & Feld LLP

DOJ’s New Corporate Compliance Evaluation Guidance

Key Considerations and Updates for Life Sciences Companies - On April 30, 2019, the Criminal Division of the U.S. Department of Justice (DOJ) issued updated guidance for white-collar prosecutors on evaluating the...more

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