Nevermind I answered my own question...Looks like its by mail
http://www.ucdmc.ucdavis.edu/clinicaltrials/IND/ind_documents/JournalofInvestigativeMedicineAugust2009.pdf" rel="nofollow" target="_blank" >http://www.ucdmc.ucdavis.edu/clinicaltrials/IND/ind_documents/JournalofInvestigativeMedicineAugust2009.pdf
SUBMITTING AN IND
A cover letter should accompany the IND submission.
Include identi?cation of the sponsor-investigator, a clear
indication that this is an initial IND submission, and ensure
that the contact information is clear and complete. Because this
is the initial IND submission, there is no IND number. Each
sequential correspondence regarding an IND should carry a
sequential identifying serial number, which, in this initial
submission, would be B0000.[ Clearly indicate the title of the
study. Take care that the contact information exactly matches
that in 1571 and 1572 to avoid any delays in communications.
Because this process is time-sensitive, delays due to communications errors can have signi?cant consequences. Send the
submission to the attention of the division that oversees the
therapeutic area for the study drug. If there has been a discussion
with an individual at CDER or CBER, they may direct the
submission to a speci?c recipient. The IND should be submitted in triplicate, namely, 1 original and 2 copies. No special binders or packaging is required.
Submission addresses:
IND submissions to CDER: Food and Drug Administration
For a Drug: Center for Drug Evaluation and
Research
Central Document Room
5901-B Ammendale Rd
Beltsville, MD 20705-1266
IND submissions to CDER: Food and Drug Administration
For a Therapeutic
Biological Product:
Center for Drug Evaluation and
Research
Therapeutic Biological Products
Document Room
5901-B Ammendale Rd
Beltsville, MD 20705-1266
IND submissions to CBER: Center for Biologics Evaluation and
Research
For a Biological Product: HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
Also http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htm#ESG" rel="nofollow" target="_blank" >http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htm#ESG
Secure Electronic Mail
Secure email between CDER and industry is useful for informal communications when confidential information may be included in the message (for example, trade secrets or patient information). Secure e-mail should not be used for formal regulatory submissions (for example, NDAs, INDs, amendments and supplements).