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  1. Development & Approval Process | Drugs

Forms & Submission Requirements

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)

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

Orphan Drug Products (for rare diseases and disorders)

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Electronic Regulatory Submission and Review

Providing Submissions in Electronic Format

Guidelines for Waiver Requests

SNOMED CT Requirements

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