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<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>RE:
US </span></font><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Food & Drug</span></font><font
size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'> </span></font><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy'>Administration</span></font><font
size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'> </span></font><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy'>Center</span></font><font
size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'> for Drug Evaluation and Research</span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><b><i><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy;
font-weight:bold;font-style:italic'> "Guidance for Industry -
Botanical Drug Products" - FINAL (</span></font></i></b><b><i><font size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy;font-weight:bold;font-style:italic'>June 9, 2004</span></font></i></b><b><i><font
size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy;font-weight:bold;font-style:italic'>)</span></font></i></b></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>The FDA
will be publishing, on </span></font><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy'>June 9, 2004</span></font><font
size=2 color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'> the FINAL VERSION of its Guidance for Industry on the development
process of botanical drugs. </span></font></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>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. </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>CONGRATULATIONS
TO FDA COLLEAGUES for all of your hard work!!</span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>Regards
-</span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>Freddie
Ann Hoffman, MD</span></font></p>
<div>
<p style='margin-left:1.0in'><font size=2 color=navy face="Times New Roman"><span
style='font-size:10.0pt;color:navy'>Freddie Ann Hoffman, MD</span></font><font
color=navy><span style='color:navy'> <br>
</span></font><b><font color=navy face="Tempus Sans ITC"><span
style='font-family:"Tempus Sans ITC";color:navy;font-weight:bold'>HeteroGeneity,
LLC</span></font></b><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>5611
16th Street, NW</span></font><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;
color:navy'>Washington</span></font><font size=2 color=navy><span
style='font-size:10.0pt;color:navy'>, </span></font><font size=2 color=navy><span
style='font-size:10.0pt;color:navy'>DC</span></font><font size=2 color=navy><span
style='font-size:10.0pt;color:navy'> </span></font><font size=2
color=navy><span style='font-size:10.0pt;color:navy'>20011</span></font><font
color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>Tel.:
202-545-6843</span></font><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>Fax:
202-545-6844</span></font><font color=navy><span style='color:navy'> <br>
</span></font><u><font size=2 color=blue><span style='font-size:10.0pt;
color:blue'>fhoffman@erols.com</span></font></u><font color=navy><span
style='color:navy'> </span></font></p>
<p><i><font size=2 color=navy face="Tempus Sans ITC"><span style='font-size:
10.0pt;font-family:"Tempus Sans ITC";color:navy;font-style:italic'>Consulting
to the regulated industry-- </span></font></i></p>
<p style='margin-left:1.0in'><font size=3 color=navy face="Times New Roman"><span
style='font-size:12.0pt;color:navy'><br>
____________________________________________________</span></font></p>
</div>
<h3 style='margin-left:1.0in'><strong><b><font size=4 color=black
face="Times New Roman"><span style='font-size:13.5pt;color:black'>FROM </span></font><font
color=navy><span style='color:navy'>June 8, 2004</span></font><font
color=black><span style='color:black'> FDA FEDRAL REGISTER PRE-PUBLICATION
ANNOUNCEMENTS</span></font></b></strong></h3>
<h3 style='margin-left:1.0in'><strong><b><font size=4 color=black
face="Times New Roman"><span style='font-size:13.5pt;color:black'>Regular
Filing -- Publishing on </span></font></b></strong><strong><b><font color=black face="Times New Roman"><span style='color:black'>June 9, 2004</span></font></b></strong></h3>
<p style='margin-left:1.0in'><b><font size=3 color=red face="Times New Roman"><span
style='font-size:12.0pt;color:red;font-weight:bold'>NOTICES-FINAL GUIDANCES</span></font></b><font
color=black><span style='color:black'> </span></font></p>
<p class=MsoNormal style='margin-left:1.0in'><b><font size=3 color=black
face="Times New Roman"><span style='font-size:12.0pt;color:black;font-weight:
bold'>Docket No. 2000D-1392, CDER 200186. Guidance for Industry on Botanical
Drug Products; Availability. [<a
href="http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-nad0002.pdf">PRE-PUB</a>] </span></font><font
color=navy><span style='color:navy'><a
href="http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-nad0002.pdf">http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-nad0002.pdf</a></span></font></b></p>
<p class=MsoNormal><b><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy;font-weight:bold'> </span></font></b></p>
<p class=MsoNormal style='margin-right:.5in;margin-bottom:0in;margin-left:1.5in;
margin-bottom:.0001pt'><b><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black;font-weight:bold'><a
href="http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-gdl0002.pdf">The Guidance</a>
</span></font><font color=navy><span style='color:navy'> <a
href="http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-gdl0002.pdf">http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1392-gdl0002.pdf</a>
</span></font></b></p>
<p style='margin-left:1.0in'><b><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black;font-weight:bold'>Docket No. 2002D-0509,
CDER 2003173</span></font></b></p>
<p class=MsoNormal style='margin-left:1.0in'><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> </span></font></p>
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style='font-size:12.0pt'> </span></font></p>
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style='font-size:12.0pt'> </span></font></p>
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