Angela Silva

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FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

6/4/2025 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform...more

6/12/2024 / Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

FDA Finalizes Framework for Transitioning from COVID-Related Medical Devices EUA/Enforcement Discretion to Permanent Marketing...

The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more

4/14/2023 / Draft Guidance , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

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