[MPWG] Fwd: MEMBER ADVISORY: FDA Approves Crofelemer as First-Ever Oral Botanical Drug

[De Angelis, Patricia]

Forwarding big news from the American Botanical Council about the FDA
approval of the second prescription botanical drug to hit the market since
2004 when the FDA developed a process for reviewing and approving botanical
drugs.

Click here for the article, MEMBER ADVISORY: FDA Approves Crofelemer as
First-Ever Oral Botanical:
http://abc.herbalgram.org/site/R?i=-0a4pXnFVkqS8dYbPniylg

As background, in 2004, the FDA published *Guidance for Industry
- Botanical Drug Products* , which is available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070491.pdf

The approval process for botanicals differs from that for synthetic, highly
purified or chemically modified drugs in significant ways, that take into
account the unique characteristics of botanically-based medicines,
including:
>a reduced emphasis on preclinical trials for botanicals that have a
history of being legally marketed in the U.S. or a foreign country, and
>it is not required to identify the active ingredient because of the
complex nature of botanical drugs.

If you would like to subscribe to the American Botanical Council email
list, click here.
http://abc.herbalgram.org/site/R?i=I8TUdcGub2FWcfOsyorrvg

American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: 512-926-4900 | Fax: 512-926-2345 | web: abc.herbalgram.org



-- 
Patricia S. De Angelis, Ph.D.
Botanist, Division of Scientific Authority-US Fish & Wildlife
Service-International Affairs
Chair, Medicinal Plant Working Group-Plant Conservation Alliance
4401 N. Fairfax Dr., Suite 110
Arlington, VA  22203
703-358-1708 x1753
FAX: 703-358-2276

Promoting sustainable use and conservation of our native medicinal plants.
<www.nps.gov/plants/medicinal>

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