Note the introduction that indicates what this guidance was intended for -
and that CBER is not listed on this particular guidance.
Note that both CBER and CDER have published similar guidance (guidances are
not legal requirements such as rules/regulations - and that is a key point).
I refer you to ICH guidance Q2B from 1997:
http://www.fda.gov/cber/ich/ichguid.htm
John G Bishop III, PhD
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication, Training, and Manufacturers Assistance
Center for Biologics Evaluation and Research/FDA
301-827-2000
800-835-4709
john.bishop@fda.hhs.gov
This communication is consistent with 21 CFR 10.85 (k) and constitutes an
informal communication that represents my best judgment at this time but
does not constitute an advisory opinion, does not necessarily represent the
formal position of FDA, and does not bind or otherwise obligate or commit
the agency to the views expressed.
-----Original Message-----
From: kmdickson@comcast.net [mailto:kmdickson@comcast.net]
Sent: Tuesday, October 03, 2006 1:11 PM
To: Bishop III, John
Subject: Criteria for method validation
http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm
Specificity
Accuracy
Precision
Linearity in and out of matrix
Limit of Quantitation
Ruggedness
Kathleen