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Holland & Knight LLP

FDA Announces Plan to Phase Out Animal Testing Requirement

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Polsinelli

Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

Polsinelli on

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more

Hogan Lovells

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

Hogan Lovells on

On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more

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