Georgia Ravitz

Orrick, Herrington & Sutcliffe LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more

1/17/2025 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Pharmaceutical Industry , Risk Management

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

1/8/2025 / Artificial Intelligence , Bias , Cybersecurity , Data Management , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Risk Management , Software , Transparency

Health Tech Regulatory Trends to Watch in 2025

Republished with Permission In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more

1/6/2025 / Artificial Intelligence , Biometric Information , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Reproductive Healthcare Issues

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more

12/23/2024 / Biotechnology , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

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