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Form Date Description Format Contact Info
3454  03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3455  03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3500  02/2006 MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3500  10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 3.5MB) MEDWATCH
1-800-FDA-1088
3500  10/2015 MedWatch: Information and Adverse Event Reporting Program - Voluntary (HTML)  (HTM - 0KB) CDER Drug Info:
(888) 463-6332
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (HTML)  (HTM - 0KB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3500A  04/2016 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 250KB) MedWatch
1-800-332-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 2.7MB) MEDWATCH
1-800-FDA-1088
3500B  10/2015 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3542  11/2013 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF - 703KB) Kendra S. Stewart
240-402-8797
3542a  11/2013 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF - 700KB) Kendra S. Stewart
240-402-8797
3671  01/2015 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF - 850KB) Kathy Needleman
301-827-3666
3674  02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) (Instructions/Supplemental)  (PDF - 129KB) Patrick McNeilly
301- 796-2941
3674  02/2015 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov (PDF)  (PDF - 2.6MB) Patrick McNeilly
301- 796-2941

Page Last Updated: 11/17/2016
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