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Vaccines, Blood & Biologics
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Resources for You
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New Drug Application (NDA) Process (CBER)
All CBER device applications should be addressed to:
FDA/CBER
1401 Rockville Pike
HFM-99, Room 200N
Rockville, MD 20852-1448
[Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH)]
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Key Resources
- Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
7/10/2008 - Questions and Answers Regarding the Complete Response Letter Rule
- Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
12/12/2007 - Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
12/26/2007 - Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme (PDF - 411KB)
FDA Form 3674
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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