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...
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...
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...
