General FDA Training: Module 1

Kalman Dubov

01/2022 · Kalman Dubov

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Clinical trials for drugs, bio-medical devices or biologics require careful attention to the requirements of the U.S. Food & Drug Administration. The Agency has several centers, each of which is focused on the three main areas of clinical investigations through the life cycle of the article. both study sponsors, as well as principal investigators, must comply with these requirements, from the time of study inception through the approval process.

This module provides an immediate overview of the Agency, with more specific information regarding drugs, bio-medical devices, and biologics. The sponsor, investigator and/or the investigator's staff, will gain from reviewing this module and by attending study sessions commonly presented by study sponsors, or their representatives by the contract research organization (CRO).

the key factor in such training is the attention to detail throughout the clinical investigation, with emphasis on maintaining written records so that the Agency audit is a smooth and professional process. I hope this module provides adequate background information enabling these professionals to successfully maneuver through these requirements with minimal frustration.

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For approximately ten years, I worked with both sponsors and principal investigators conducting clinical trials for drugs, bio-medical devices, and/or biologics. At the time, I had two national certifications: CIP (IRB) and RAC, the latter with expertise regarding the US Food & Drug Administration (FDA).