On October 1, 2003, FDA transferred responsibility for regulating most therapeutic biologics, with certain exceptions (e.g., cell and gene therapy products and therapeutic vaccines), from the Office of Therapeutics Research and Review (OTRR), Center for Biologics Evaluation and Research (CBER), to the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), and the Office of Pharmaceutical Science (OPS), CDER. Applications for the therapeutic biological products now under CDER's review, including INDs, biologics license applications, investigational device exemptions, and new drug applications, were transferred to CDER. For more information, see Transfer of Therapeutic Products to CDER.
The consolidation of INDs transferred from CBER to CDER has resulted in duplicate IND numbers. To resolve this issue, INDs numbered below 14,000 that were submitted to CDER before the consolidation will be assigned new numbers. To determine the new number, CDER has added 80,000 to the original IND number. For example, IND 8,999 will become IND 88,999 and IND 11,192 will become 91,192. INDs that were originally submitted to CBER and transferred to CDER will retain their numbers.
- Federal Register Notice (PDF - 45KB) (11/17/2005)