draft of Guidance for Industry Botanical Drug Products
Published August 10, the guidance details
when a botanical drug may be marketed under an over-the-counter
drug monograph or a new drug application and includes guidelines
for "submitting investigational new drug applications (INDs) for
botanical drug products, including those...currently... marketed
as foods and dietary supplements." The guidance also allows manufacturers
to "submit reduced documentation of preclinical safety and of
chemistry, manufacturing, and controls (CMC) to support an IND
for initial clinical studies of botanicals that have been legally
marketed in the United States as dietary supplements or cosmetics."
Comments on the draft must be submitted by October 9. To view
the draft, visit www.fda.gov/cder/guidance/ 1221dft.pdf. FDA
website, August 11, 2000; www.naturalproductsinsider.com
© 2003 by Herb Research Foundation,
Boulder, CO, USA.