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Instructions for Form FDA356h
for the current year.
Instructions for 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.
Instruction Details:
- This 5-page document is available for download in PDF;
- Actual and applicable for the current year;
- Complete, printable, and free.
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