Pre-IND consultation program

The only division in CDER with an established policy regarding pre-IND consultation meetings is the Division of Anti-Viral Drug Products (DAVDP). Established in 1988, the DAVDP pre-IND Consultation Program is a proactive strategy designed to facilitate informal early communications between DAVDP and potential sponsors of new therapeutics for the treatment of AIDS and life-threatening opportunistic infections, other viral infections, and soft tissue trans-... 

A great majority of botanical sponsors have taken advantage of the pre-IND consultation service provided by FDA. As a result, most IND applications were successful with initial submission and few (less than 20) were placed on clinical hold for safety concerns. However, despite the early success, many development programs and research projects have subsequently been suspended for various reasons. As of the above-mentioned cutoff date (April 30, 2004), nearly two-thirds (66%) of INDs still remain active (have not been placed on clinical hold, inactivated by FDA, or withdrawn by sponsor for lack of activities). To date, there have been no submissions of NDAs to FDA for marketing approval of botanical prescription drugs. 

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