FDA Forms
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| Form | Date | Description | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 08/2018 | Application to Market a New or Abbreviated New Drug or Biologic for Human Use(PDF) At this time, the attached PDF document may not be fully accessible to readers using assistive technology. In the event you are unable to read and/or complete portions of the form, please contact CDER at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov | (PDF - 2.4MB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 0356h | 08/2018 | Application to Market a New or Abbreviated New Drug or Biologic for Human Use (Instructions Supplement) | (PDF - 185KB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 0421 | 07/2003 | Sample Accountability Record (ORA) (PDF) | (PDF - 389KB) |
William Campanaro 240 821 6667 |
| 0431 | 01/2015 | Analyst Worksheet (ORA) (PDF) | (PDF - 1MB) |
William Campanaro 240 821 6667 |
| 0431a | 05/1984 | General Continuation Sheet (PDF) | (PDF - 1.4MB) |
William Campanaro 240 821 6667 |
| 0431d | 08/2012 | Bacteriological Record (PDF) | (PDF - 1.2MB) |
William Campanaro 240 821 6667 |
| 0431e | 09/2011 | Industrial Chemicals Worksheet (PDF) | (PDF - 389KB) |
William Campanaro 240 821 6667 |
| 0431f | 11/1989 | Quantity of Contents (PDF) | (PDF - 337KB) |
William Campanaro 240 821 6667 |
| 0431j | 08/1985 | Botulism Continuation Sheet (PDF) | (PDF - 6KB) |
William Campanaro 301-827-1036 |
| 0431k | 08/1985 | Shellfish Bacteriological Record (PDF) | (PDF - 8KB) |
William Campanaro 301-827-1036 |
| 0431m | 12/1979 | Elemental Analysis Worksheet (PDF) | (PDF - 6KB) |
William Campanaro 240 821 6667 |
| 0465 | 08/1985 | Sample Summary (DOC) | (PDF - 221KB) |
William Campanaro 240 821 6667 |
| 0482d | 09/2017 | Request for FSVP Records (PDF) | (PDF - 1MB) |
Brian Ravitch 619 941-3719 |
| 0483a | 02/2016 | FSVP Observations (PDF) | (PDF - 1.7MB) |
Brian Ravitch 619 941-3719 |
| 0766 | 01/2018 | Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts (PDF) | (PDF - 660KB) |
John Verbeten 301-796-6677 |
| 1551 | 05/2011 | Report of Sample Analysis (PDF) | (PDF - 353KB) |
William Campanaro 240 821 6667 |
| 1551b | 01/1993 | Report of Sample Analysis (Aflatoxins) (PDF) | (PDF - 337KB) |
William Campanaro 240 821 6667 |
| 1570 | 04/1978 | Summary of Bacteriological Results (PDF) | (PDF - 302KB) |
William Campanaro 240 821 6667 |
| 1571 | 04/2019 | Investigational New Drug Application(IND)(PDF) At this time, the attached PDF document may not be fully accessible to readers using assistive technology. In the event you are unable to read and/or complete portions of the form, please contact CDER at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov | (PDF - 2.1MB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 1571 | 04/2019 | Investigational New Drug Application (IND) [Instructions] | (PDF - 178KB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 1572 | 07/2013 | Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance) | (PDF - 108KB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 1572 | 03/2019 | Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312)(PDF) At this time, the attached PDF document may not be fully accessible to readers using assistive technology. In the event you are unable to read and/or complete portions of the form, please contact CDER at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov | (PDF - 1.4MB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 1609 | 03/1986 | Research Project Record (PDF) | (PDF - 337KB) |
William Campanaro 301-827-1036 |
| 1609a | 03/1986 | Research Progress Record (PDF) | (PDF - 349KB) |
William Campanaro 301-827-1036 |
| 1815 | 08/2018 | Certificate/ Transmittal for an Application (PDF) | (PDF - 614KB) |
Esther Lazar 240-402-1485 |
| 1932 | 07/2016 | Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF) | (PDF - 945KB) |
Margarita Brown 240-402-5740 |
| 1932a | 08/2018 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF) | (PDF - 842KB) |
Linda Walter-Grimm 240-402-5762 |
| 1932a | 08/2018 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report (dynamic)(PDF) | (PDF - 171KB) |
Linda Walter-Grimm 240-402-5762 |
| 1993 | 08/2018 | Application for Permit to Ship or Transport Milk and/or Cream into US (PDF) | (PDF - 741KB) |
Esther Lazar 240-402-1485 |
| 1994 | 01/2019 | Report of Tuberculin Tests of Cattle (PDF) | (PDF - 192KB) |
Esther Lazar 240-402-1485 |
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