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FDA Announces Release of Guide on Botanical Drug Development

September 15, 2015

UNITED STATES  ̶   The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance for industry entitled "Botanical Drug Development," modifying its earlier guidance released in June 2004 under the name "Botanical Drug Products." This new guidance addresses practices related to:

  • Proper development plans for botanical drugs to be submitted in new drug applications (NDAs); and
  • Specific recommendations on submission of investigational new drug applications (INDs).It also includes general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Other principles covered may also apply for botanical drugs to be marketed under biologics license applications (BLAs).

Comments on the draft guidance may be submitted until October 16, 2015.