Drug Application Forms and Electronic Submissions

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FDA 1571. Investigational New Drug Application
FDA 1572. Statement of Investigator
Instructions for completing FDA forms 1571 and 1572
FDA Form Distributions Page. includes links to:
Certification: Financial Interest and Arrangements of Clinical Investigators
Disclosure: Financial Interest and Arrangements of Clinical Investigators
MedWatch: FDA Medical Product Reporting Program - Voluntary
MedWatch: FDA Medical Products Reporting Program - Mandatory
For electronic form submissions, see Electronic Regulatory Submissions and Review.

Form FDA-356h. Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use
Form FDA-3397 User Fee Cover Sheet
Form FDA-3331. New Drug Application Field Report
For electronic form submissions, see Electronic Regulatory Submission and Review.

FDA Form 356h. Application to Market a New Drug for Human Use/Antibiotic Drug for Human Use
The CDER Office of Generic Drugs has developed a guidance document entitled Providing Regulatory Submissions in Electronic Format — ANDAs [PDF version] (Issued 6/2002, Posted 6/27/2002) to assist applicants making regulatory submissions in electronic format of abbreviated new drug applications. This guidance should be used in conjunction with the following guidances:
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations.
- Regulatory Submissions in Electronic Format; New Drug Applications.
For electronic form submissions, see Electronic Regulatory Submissions and Review

There is no form, but there is a prescribed format for application for orphan drug status. The section from the regulations that describes the format can be found on this website on the The Orphan Drug Act and Related Law and Regulations page.

Regulations and Instructions for Submitting Drug Applications Electronically. This webpage provides for information on CDER's program to enable the electronic submission of regulatory information to the Center and the review of it by CDER staff.

FDA/Center for Drug Evaluation and Research
Last Updated: July 17, 2002
Originator: OTCOM/DML
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