FDA Forms
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| Form | Date | Description | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 09/2017 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement) | (PDF - 175KB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 0356h | 08/2017 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (PDF) (Recommended for use with Adobe Acrobat 8 or 9) | (PDF - 2.3MB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 0356v | 04/2008 | New Animal Drug Application [VET] (Q&As on the Revised 356v Form) | (HTM - 0KB) |
Urvi Desai 240-402-0689 |
| 0356v | 08/2016 | New Animal Drug Application [VET] (PDF) | (PDF - 853KB) |
Urvi Desai 240-402-0689 |
| 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 | 07/2017 | Investigational New Drug Application (IND) [Instructions] | (PDF - 171KB) |
CBER MATT at 240-402-8020 CDER Drug Info at 301-796-3400 |
| 1571 | 08/2017 | Investigational New Drug Application (IND) (PDF) (Recommended for use with Adobe Acrobat 8 or 9) | (PDF - 1.4MB) |
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 | 02/2016 | Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF) | (PDF - 1.1MB) |
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 | 10/2015 | Certificate/ Transmittal for an Application (PDF) | (PDF - 602KB) |
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 | 07/2016 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report (dynamic)(PDF) | (PDF - 161KB) |
Margarita Brown 240-402-5740 |
| 1932a | 07/2016 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF) | (PDF - 811KB) |
Margarita Brown 240-402-5740 |
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