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CDER Investigational New Drug (IND) Renumbering
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), CBER, to the Office of New
Drugs (OND), 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 on the transfer of
therapeutic biological products from CBER to CDER, see FDA’s Web
page at
http://www.fda.gov/cber/transfer/transfer.htm.
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 [TXT]
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Date created: November 17, 2005 |
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