FDA CDER Guidelines

FDA CDER Guidelines by a Senior Officer on GMP Inspections

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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How to Successfully Complete an FDA Inspection

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White Paper: How to Successfully Complete an FDA Inspection White Paper: The Value of Studying and Utilizing FDA's QSIT Manual White Paper: FDA Inspections of Clinical Investigators: Are You Ready? White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
Kit: 11 Free Resources to Boost Your FDA Readiness

FDA CDER Guidelines that were Provided during Q&A Interview

This question-and-answer white paper provides FDA CDER guidelines and addresses the following:

The 12 most common problems pertaining to quality audit
Things that FDA investigators look for in terms of CAPA
What FDA investigators look for in terms of training control
How medical device companies can apply a 'risk-based' approach to quality management
What medical device firms ought to do prior to an FDA inspection

Role of FDA CDER Guidelines

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.