Instructions for Form FDA356h Application to Market a New or Abbreviated New Drug or Biologic for Human Use

Form FDA356H Application to Market a New or Abbreviated New Drug or Biologic for Human Use

This document contains official instructions for Form FDA356h , Application to Market a New or Abbreviated New Drug or Biologic for Human Use - a form released and collected by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration. An up-to-date fillable Form FDA356H is available for download through this link.

FAQ

Q: What is Form FDA356h?
A: Form FDA356h is an application form used to request approval for marketing a new or abbreviated new drug or biologic for human use.

Q: Who can use Form FDA356h?
A: Manufacturers and sponsors of new or abbreviated new drugs or biologics for human use can use Form FDA356h.

Q: What is the purpose of Form FDA356h?
A: The purpose of Form FDA356h is to provide the necessary information for the FDA to evaluate the safety and effectiveness of the drug or biologic being proposed for marketing.

Q: What information is required in Form FDA356h?
A: Form FDA356h requires detailed information about the manufacturer, product, clinical trials, labeling, and other relevant data related to the drug or biologic.

Q: How should Form FDA356h be submitted?
A: Form FDA356h should be submitted electronically using the FDA's Electronic Submission Gateway or CD/DVD.