Investigational New Drug Forms (IND)

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.

New Drug Application Forms (NDA)

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 Form FDA-3331 Instructions (pdf) New Drug Application Field Report

Abbreviated New Drug Application Forms (ANDA) for Generic Drug Products

Form FDA-356h (pdf) Application to Market a New Drug, Biologic or An Antibiotic Drug For Human Use Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations.

Orphan Drug Products (for rare diseases and disorders)

• 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.

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Electronic Regulatory Submission and Review

• 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.

Providing Submissions in Electronic Format

• Guidance for Industry: Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER
  • Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning

Guidelines for Waiver Requests

• 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.

SNOMED CT Requirements

• NEW SNOMED CT will be required for FDA Forms 1571 and 356h. The instructions on how to fill out the SNOMED CT Indication Disease Term on the Forms 356h and 1571 see FDA Forms and SBIA Webinar. For more information on SNOMED CT see FDA Data Standards Catalog and Technical Conformance Guide.  
   

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