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About FDA
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FDA Forms
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| Form | Date | Food and Drug Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 3454 | 10/2009 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 384KB) |
Leah W. Ripper 301-796-1282 |
| 3455 | 10/2009 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 400KB) |
Leah W. Ripper 301-796-1282 |
| 3500 | 02/2006 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML) | (HTM - 0KB) |
MEDWATCH 1-800-FDA-1088 |
| 3500 | 01/2009 | MedWatch: The FDA Safety Information and Adverse Reporting Program | (PDF - 1.7MB) |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - | (PDF - 1.4MB) |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions) | (HTM - 0KB) |
MedWatch 1-800-332-1088 |
| 3542 | 10/2010 | Patent Information Submitted Upon and After Approval of An NDA or Supplemen | (PDF - 412KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3542a | 10/2010 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supp | (PDF - 409KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3671 | 11/2011 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | (PDF - 569KB) |
Kathy Needleman 301-827-3666 |
| 3674 | 03/2012 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme | (PDF - 406KB) |
Jarilyn Dupont 301-796-4716 |
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