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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 used to request permission to market a new or abbreviated new drug or biologic for human use.
Q: Who needs to submit Form FDA356H?A: Any individual or organization seeking to market a new or abbreviated new drug or biologic for human use needs to submit Form FDA356H.
Q: What is the purpose of Form FDA356H?A: The purpose of Form FDA356H is to provide the necessary information and documentation for the Food and Drug Administration (FDA) to evaluate the safety and effectiveness of the proposed drug or biologic.
Q: What should be included in Form FDA356H?A: Form FDA356H should include information such as the drug's composition, intended use, manufacturing process, proposed labeling, and data from relevant clinical trials.
Q: Are there any fees associated with submitting Form FDA356H?A: Yes, there are fees associated with submitting Form FDA356H. The amount depends on the type of application and the size of the applicant's organization.
Q: Is there a deadline for submitting Form FDA356H?A: There is no specific deadline for submitting Form FDA356H. However, it is recommended to submit the application well in advance of the desired marketing date.
Q: Are there any other forms or documents required in addition to Form FDA356H?A: Yes, there may be additional forms or documents required depending on the specific circumstances. It is advisable to consult the FDA's guidance documents or contact the FDA for further information.
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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