Sunday, November 2, 2008

How The FDA Regulates Botanical Drugs

You have to read this. In an issue of Nature Biotechnology, you'll learn how FDA personnel review applications to test botanical drugs in humans, and market those products in the US as reported in this article, "New therapies from old medicines - Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met (pdf)." In general, here's what it's all about . . .

  1. From dietary supplements to new drugs
  2. Current US regulatory environment
  3. Review of botanical applications at CDER
  4. Analysis of botanical drug IND submissions
  5. Unique regulatory issues
  6. Botanicals as variable, complex mixtures
  7. Botanicals as multiple-plant combinations
  8. Previous human use of botanicals
  9. Botanicals marketed as dietary supplements

It's encouraging to me to see these kinds of articles appearing on the topic. Personally, I'd consider using more botanicals if I can see that some form of rigor is applied to them.

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