All links provided below will direct you to the respective resource on the FDA website.
Overview on NDA
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FAQs on therapeutic biological products
Guidance for Industry S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals – July 1997
Guidance for Industry S6 Addendum Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals – May 2012
FDA webpage summarizing 4 programs
Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics – May 2014