Update of the BIMO Guidance Manual

USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff

FDA’s Compliance Program consists of several separate parts. “7348.810-Bioresearch Monitoring” is one of them. On the cover page, it shows an “Implementation Date” of April 19, 2017, however under “REVISION”, there is no date mentioned. It only says “COMPLETION DATE – Continuing”. For those of you who thought this is a new document; it is not. It has been around for a long time and has been updated regularly, the last update being the April 2017 version that constitutes a major revision.

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