Center for Drug Evaluation and Research (CDER)

The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the FD&C Act and reviews new drug applications to ensure that the drugs are safe and effective.

Case Study

Food and Drug Administration (FDA) Statistical Analysis Expert

A food and drug administration (FDA) statistical analysis expert was needed for a patent dispute that arose in connection with a request for FDA approval for the commercial manufacture, use, and sale of a generic drug.

Case Study

Biotechnology Expert in Clinical Trials

A biotechnology expert with knowledge of FDA clinical trials and procedures was requested for an arbitration case involving biotherapeutics.