LaDale K. George Partner

The U.S. Food and Drug Administration (FDA) released a new set of guidelines on August 15, 2023, concerning informed consent (Final Guidance).

On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.”

The Food and Drug Administration recently revised its regulations governing submission and approval of new drug applications and abbreviated new drug applications. In the patent space, the America Invents Act provides a streamlined administrative process for challenging the validity of pharmaceutical (and other) patents. Congress also created an abbreviated pathway for biosimilar products, including a regulatory scheme for handling related patent disputes.