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IND Requirements and Exemptions

Does my product require an Investigational New Drug (IND) application? It’s a simple question, but the answer can have extensive consequences for your development program. In this post, we will…

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FDA Approved

Communicating Effectively with the FDA

One of the most important aspects of any drug development program is the stream of interactions with regulatory authorities like the US Food and Drug Administration (FDA). These interactions can…

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Cancer T-cells

Key Hurdles in Immuno-Oncology

Immuno-oncology is an exciting but challenging subspecialty that falls underneath the umbrella of oncology research and development. Unlike more traditional oncology treatments that target the tumor itself (albeit sometimes rather…

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