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 | Sep 29, 2022 | Biotech Bulletin, News
While many biotech and life-science companies have impeccable products and intellectual property pipelines, they are often in need of appropriate capital to execute the company’s mission. There are numerous ways to raise capital, from many different markets (private...
by Ismail Amin | Aug 24, 2022 | Biotech Bulletin, News
In the second part of the clinical trials series, we examine the duties and obligations of Sponsors and Clinical Research Organizations (CRO) as it relates to the protection of human subjects who participate in clinical trials. Generally, a “Human Subject” is an...
by Ismail Amin | Aug 15, 2022 | Biotech Bulletin, News
In the selection of a Clinical Research Organization (CRO), the Sponsor must ensure that the CRO has careful policies and procedures in place to safeguard protected patient information. Also, Sponsors should evaluate their own privacy protection policies and SOPs in...
by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News
FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements. In its July 25, 2022, guidance document – The FDA (by and through the Center for Biologics Evaluation and Research and...
