Drug Trials, FDA Approval and Pharmaceutical Companies

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

In spite of current success and possibility to be a successful cell technology model, the integration of organ-on-chips into drug development process needs more optimisation to be validated for FDA approval. Nature Cancer. 2022;3(4):418-36. Passini E, Britton OJ, Lu HR, Rohrbacher J, Hermans AN, Gallacher DJ, et al.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

An Evolving Regulatory Environment for Rare and Orphan Diseases

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Disease

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Drug Discovery Digest

Advanced 3D cell-based technologies

An Evolving Regulatory Environment for Rare and Orphan Diseases

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