In a telephone interview, Kristen Evans, a senior regulatory operations officer at the Office of Compliance in the FDA's Center for Drug Evaluation and Research ( FDA CDER ), provided insights on issues commonly encountered by companies seeking compliance with FDA CDER guidelines.
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This question-and-answer white paper provides FDA CDER guidelines and addresses the following:
As noted in the Q&A on FDA CDER Guidelines (which you can download above), the role of the FDA's CDER is to promote and protect public health by ensuring that all prescription and over-the-counter drugs sold in the U.S. are safe and effective. CDER's Office of Compliance monitors the quality of marketed drugs through inspections, product testing, surveillance, and other compliance programs.
The office of FDA CDER also develops standards for current good manufacturing practices (CGMP), clinical and good laboratory practices, and industry practices.
For more information about GMP or FDA CDER guidelines, please feel free to contact a MasterControl representative.