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Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information for compliance with the regulations of the FDA.
For clinical investigators who are not familiar with FDA regulations and the guidance that the Agency provides for good clinical practice, CDER advises that there are two sources of information which investigators should read first.
-Federal Regulations for Clinical Investigators contains Code of Federal Regulations pertaining to the responsibilities of clinical investigators.
-Guidance for Industry: Good Clinical Practice Consolidated Guideline.(E6, 63 pp) This guidance, developed with the European Union, Japan, and other countries represents the Agency's current thinking on good clinical practice, and contains 62 definitions of terms used in clinical trials.(1)
CDER's point:

Clinical trials represent the ultimate premarket testing ground for unapproved drugs. During these trials, an investigation compound is administered to humans and is evaluated for its safety and effectiveness in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug.
Although the goal of clinical trials is to obtain safety and effectiveness data, the overriding consideration in these studies is the safety of those in the trials. CDER monitors the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks.

Update your CDER bearings:
http://www.fda.gov/cder/cderorg/cder-all.pdf showing the updated CEDER org. chart-June 20th 2008
http://www.fda.gov/cder/guidance/CompList06-2008.pdf a comprehensive "guidance" listing/dates
(1) E6 Guidance document: http://www.fda.gov/cder/guidance/959fnl.pdf

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This page contains a single entry from the blog posted on July 2, 2008 1:27 PM.

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