All posts tagged CDER

There’s a very good explanation for what the function of the CDER (Center for drug evaluation and research) at the FDA’s own FAQ page found here:

Wikipedia also has a good definition:

CDER reviews New Drug Applications to ensure that the drugs are safe and effective. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed.

The FDA publishes Guidance for Industry documents. One such document is for the Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production which details guidance that applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods.