FDA Part 11 Committee Changes

FDA’s internal Part 11 working group (responsible for interpretation, enforcement, and guidance development) has had some significant changes. These changes indicate that FDA may be trying to accelerate resolution of interpertational issues and industry concerns.
The leadership of the working group has been shifted from the Office of Regulatory Affairs (ORA) back to the Center for Drug Evaluation and Research (CDER). The shift back to CDER leadership (CDER initiated and initially led interpertation of Part 11) appears to be part of its new cGMP initiative to take a risk based approach (CDER lags CDRH in this) to streamline regulation while assuring safety and effectiveness. A concept paper issued by CDER is at the link provided. At the end of the paper it mentions considering changes to regulations including 21 CFR Part 11.

John Taylor, Director of Enforcement for ORA the former Part 11 working group leader is no longer on the working group but is on a steering committee for this group. The new leader is Joseph Formulare of CDER.

It is our understanding that other members of the steering committee include Dan Troy (FDA Chief Counsel) and Janet Woodcock Director of the Center for Biologics (CBER). At the present time there is no Center for Devices and Radiological Health (CDRH) representation on the steering committee but there is CDRH representation on the working group.

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