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CDR Library Release 2.0 Version Number: 2.0 Version Date: 5/30/2017User Guide Common Data Element Repository (CDR) Library, Release 2.0Table of Contents 1. Purpose ...................................................................................................................................................................4

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What is cder library?

The CDER (Center for Drug Evaluation and Research) library is a collection of documents related to drug evaluation and research.

Who is required to file cder library?

Pharmaceutical companies and drug developers are required to file the CDER library.

How to fill out cder library?

The CDER library can be filled out online through the FDA's electronic submission portal.

What is the purpose of cder library?

The purpose of the CDER library is to provide a centralized location for important drug evaluation and research documents.

What information must be reported on cder library?

Information such as drug development data, clinical trial results, and safety information must be reported on the CDER library.

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