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1 Oct 2017

What is USFDA form 356h?

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FDA 356h form is the application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use. Applicant who want to submit BLA or NDA to USFDA need to file in the 356h form.

Form 356h specifies the requirements for a BLA. This includes:

  • Applicant information
  • Product/manufacturing information
  • Pre-clinical studies
  • Clinical studies
  • Labeling

What after submission to 356h form to USFDA?

A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.

A BLA asserts that the product is “safe, pure, and potent”, the manufacturing facilities are inspectable, and each package of the product bears the license number.

After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.

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