Assignment of Applications for Products to Reduce the Risk of Cancer

New Mailing Address for Submissions for Cancer Risk Reduction Products (excluding products to prevent non-melanoma skin cancer).

Important update for mailing submissions for products to reduce the risk of cancer, excluding non-melanoma skin cancer.

As of December 15, 2004, submissions for all drugs intended to decrease the risk of cancer (EXCLUDING drugs to reduce the risk of non-melanoma skin cancer; 21 CFR 600.80 postmarketing adverse experience reports; advertising and promotional labeling; and 21 CFR 600.14 biological product deviation reports) should be sent to:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Oncology Drug Products
5901-B Ammendale Road
Beltsville, MD 20705-1266

As of December 15, 2004, submissions for all biologic products regulated by CDER that are intended to decrease the risk of cancer (excluding 21 CFR 600.80 postmarketing adverse experience reports; advertising and promotional labeling; and 21 CFR 600.14 biological product deviation reports) should be sent to:

Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266

On July 29, 2004, FDA announced the formation of the Office of Oncology Drug Products, to provide for an even stronger and more consistent approach to the review process for most drugs and therapeutic biologics used to treat and reduce the risk of cancer. In order to achieve this goal, most applications to reduce cancer risk have been transferred from review divisions within CDER to the Division of Oncology Drug Products (DODP) in ODE I, a division that will become part of the new Office when the planned Office of New Drugs (OND) reorganization is complete. Exceptions include products to reduce the risk of non-melanoma skin cancer, which will continue to be reviewed in the Division of Dermatologic and Dental Drug Products (DDDDP), and CDER-regulated biologic products to reduce cancer risk, which will continue to be reviewed in the Division of Therapeutic Biological Oncology Products (DTBOP) in ODE VI, a division that will be part of the new office when the OND reorganization is complete. The DODP now has regulatory responsibility, including premarket review and continuing oversight, over the transferred products. In regulating the products assigned to them, DODP will consult divisions with organ- and disease-specific expertise regularly and whenever necessary. For clarity, products to reduce the risk of cancer are referred to as “prevention” products.

• Cancer prevention applications were transferred in groups between December 15, 2004 and January 31, 2005
• As of December 15, 2004, all new INDs, NDAs, BLAs, and supplemental NDAs/BLAs for cancer prevention should be submitted to DODP, DDDDP, or DTBOP as appropriate
• These reassignments refer only to products to reduce the risk of cancer, not products to treat cancer

For further information about the new organizational structure, see:

• FDA to Establish New Cancer Office and Program: Changes Designed to Improve Efficiency and Consistency of Cancer Product Reviews, July 16, 2004 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108326.htm
• FDA Office of Oncology -- Questions and Answers, July 16, 2004 http://www.fda.gov/oc/initiatives/oncology/questions.html

The lists below identify categories of cancer prevention products transferred from OND review divisions to DODP and categories of cancer prevention products that will not be transferred. Please note that the DDDDP list contains only a portion of the cancer prevention products DDDDP currently regulates.

Categories of Cancer Risk Reduction Products transferred to DODP

• Gastrointestinal cancer risk reduction
• Gynecologic cancer risk reduction
• Genitourinary cancer risk reduction
• Lung cancer risk reduction
• Aerodigestive tract cancer risk reduction, including products to reduce the risk of cancer in patients with oral leukoplakia

Categories of Cancer Risk Reduction Products not transferred

• Non-melanoma skin cancer risk reduction, which will continue to be regulated in DDDDP
• CDER-regulated biologic products to reduce the risk of cancer, which will remain in DTBOP, a division that will be part of the new Office of Oncology Drug Products
• Products for the early detection of cancer, which will remain in their current divisions

Approved Products transferring to DODP (for cancer prevention indications only)

Sponsor Information

Files transferring to DODP:

• NDAs Transferring to CDER   
• INDs Transferring to CDER

Questions about the assignment of specific products to DODP, DTBOP, or DDDDP should be directed to :

Ms. Dotti Pease, CPMS
Division of Drug Oncology Products
(301) 796-1434
dorothy.pease@fda.hhs.gov

Ms. Karen Jones, CPMS
Division of Biologic Oncology Products
(301) 796-1377
karen.jones@fda.hhs.gov

Ms. Mary Jean Kozma-Fornaro, CPMS
Division of Dermatology and Dental Products
(301) 796-0937
mary.kozma-fornaro@fda.hhs.gov

Mr. Matthew Bacho
Office of New Drugs, Immediate Office
(301) 796-0067
matthew.bacho@fda.hhs.gov

NDAs Transferring to DODP

INDs Transferring to DODP

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Date created: March 8, 2005, updated October 27, 2005