FDA - new Revised AER Guidance Doc for public comment

[Guest guest]

FDA has revised the draft guidance on AERs originally issued in early

January of this year. The revised draft guidance can be viewed at this

link http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0209-gdl.pdf

FDA is requesting comments on this revision; there is no comment

deadline http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0847.pdf

Main points of the revised draft guidance can be summarized as follows:

* FDA continues to interpret " domestic address " as meaning the

full street address

* FDA continues to recommend a prefatory statement be added to

the label alerting consumers that the full address is for the purpose of

reporting adverse events to the company

* FDA has extended the compliance deadline to January 1, 2010

S. Kalman PhD, RD, CCRC, FACN

Miami Research Associates

Director, Nutrition & Applied Clinical Research

6141 Sunset Drive #301

Miami, FL. 33143

(fax)

www.miamiresearch.com <http://www.miamiresearch.com>