[MPWG] FW: FDA Publishes FINAL GUIDANCE DOC for Botanical Drug Development

Tue Jun 8 16:17:51 CDT 2004

RE:   US Food & Drug Administration Center for Drug Evaluation and Research

 "Guidance for Industry - Botanical Drug Products"  - FINAL (June 9, 2004)

The FDA will be publishing, on June 9, 2004 the FINAL VERSION of its
Guidance for Industry on the development process of botanical drugs. 

The Draft Guidance was originally published in August 2000.   That document
was available for public comment.   The agency has incorporated those
comments into a final document.  The Final Guidance includes a Q & A Section
(at the end) to address common inquiries regarding the process.  

CONGRATULATIONS TO FDA COLLEAGUES for all of your hard work!!

Regards -

Freddie Ann Hoffman, MD

Freddie Ann Hoffman, MD 
HeteroGeneity, LLC 
5611  16th Street, NW 
Washington, DC  20011 
Tel.:  202-545-6843 
Fax:  202-545-6844 
fhoffman at erols.com 

Consulting to the regulated industry-- 

____________________________________________________

FROM June 8, 2004 FDA FEDRAL REGISTER PRE-PUBLICATION ANNOUNCEMENTS

Regular Filing -- Publishing on June 9, 2004

NOTICES-FINAL GUIDANCES 

Docket No. 2000D-1392, CDER 200186.  Guidance for Industry on Botanical Drug
Products; Availability.  [PRE-PUB
<http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-nad0002.pdf> ]
http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-nad0002.pdf

The Guidance <http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-gdl0002.pdf>
http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-gdl0002.pdf 

Docket No. 2002D-0509, CDER 2003173

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