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Artificial Intelligence and the Implications for Drug Manufacturers (FDA Discussion)

Artificial Intelligence and the Implications for Drug Manufacturers (FDA Discussion)

by Ismail Amin | Mar 6, 2023 | artificial intelligence, Biotech Bulletin, Business Law, Healthcare, Life Sciences, News

On March 1, 2023, the FDA’s Center for Drug Evaluation and Research (CDER) issued a discussion paper on the role of Artificial Intelligence (AI) in the context of drug manufacturing and the implications for “measurement, modeling, and control technologies used in...
When Software is a Medical Device: The FDA Guidance on Premarket Submissions for Device Software Functions

When Software is a Medical Device: The FDA Guidance on Premarket Submissions for Device Software Functions

by Ismail Amin | Mar 28, 2022 | Healthcare, News

Are smartwatches and smartphones now considered “Medical Devices” under the Food Drug & Cosmetic Act? Questions like these have began percolating throughout the world as consumer based devices become more sophisticated and provide medical information to consumers...
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