Oluwaremilekun Mehner

Akin Gump Strauss Hauer & Feld LLP

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Software and Digital Health Policies Issued by FDA

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

4/6/2023 / Artificial Intelligence , Cybersecurity , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

4/4/2023 / De Novo Standard of Review , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022 / Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees

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