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Clinical Trial Design Best Practices

Clinical Trial Design Best Practices

by Ismail Amin | Jul 3, 2023 | Biotech Bulletin, Healthcare, Life Sciences, News

In its most recent guidance, “E6 R# Good Clinical Practice (GCP)”, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the FDA emphasized their current thinking on the principles of ICH GCP, underscoring...
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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