FDA (CDRH) will soon (July 27, 2006) hold a public meeting about
Bayesian statistics in medical device clinical trials.
On May 23rd CDRH released "Draft Guidance for Industry and Food and Drug
Administration Staff; Guidance for the Use of Bayesian Statistics in
Medical Device" for public comment.
You can download this guidance at
http://www.fda.gov/cdrh/osb/guidance/1601.html. It covers BUGs.
This draft guidance provides FDA's recommendations on the use of
Bayesian statistical methods in the design and analysis of medical
device clinical trials. Development of this guidance was influenced by
CDRH's unique experience in planning and evaluating Bayesian clinical
trials in the regulatory setting. This draft guidance is neither final
nor is it in effect at this time. The public can submit written or
electronic comments on this draft guidance to Docket No. 2006D-0191 for
a period of 90 days, until August 21, 2006.
CDRH will hold a public meeting to address the draft guidance at The
Universities of Shady Grove, 9630 Gudelsky Drive, Rockville, MD, from
8:30 - 5:00 on Thursday, July 27, 2006.
Directions to Shady Grove:
On-line registration (without charge) is available or contact:
* Bridgette Stein, Public Health Analyst, Division of Biostatistics,
* Cindy Garris, Public Health Advisor, Division of Small Manufacturers,
International, and Consumer Assistance, 240-276-3150 x 121
Daniel M. Byrd III, Ph.D., D.A.B.T.
Life Sciences Research Office
9650 Rockville Pike
Bethesda, MD 20814-3998
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