Drugs

Forms & Submission Requirements

FDA 1571 (pdf) Investigational New Drug Application
FDA 1572 (pdf) 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 (pdf) Application to Market a New Drug, Biologic, or An Antibiotic Drug For Human Use
Form FDA-3397 (pdf) User Fee Cover Sheet
Form FDA-3331 (pdf) New Drug Application Field Report

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.

Guidelines for requesting waiver to current supported clinical study data standard versions. This webpage provides information on submission of data that does not conform to currently supported standard versions.