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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...
The Capital Raise – Best Practices for Biotech

The Capital Raise – Best Practices for Biotech

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...
Clinical Trials – Protection of Human Subjects and the Role of Institutional Review Boards (IRB)

Clinical Trials – Protection of Human Subjects and the Role of Institutional Review Boards (IRB)

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...
Clinical Research Organizations (CRO) – Patient Recruitment & Privacy Considerations

Clinical Research Organizations (CRO) – Patient Recruitment & Privacy Considerations

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...
FDA Provides GUDID Submission Requirements Guidance

FDA Provides GUDID Submission Requirements Guidance

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...
FDA Issues NDA and BLA Recommendations Warranting RTOR

FDA Issues NDA and BLA Recommendations Warranting RTOR

by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News

FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real time Oncology Review (RTOR). On July 25, 2022, the FDA, by and through the Oncology Center for...
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