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 | Feb 24, 2020 | Life Sciences, News
The therapeutic, ethical and legal implications of gene editing and CRISPR technologies are both profound and complex. However, before we delve into the potential panacea of gene editing technologies, a basic framework and understanding of how it all works is...
