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What is form 356h
20 Oct 2023

What is form 356h?

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The FDA Form 356h is a specific document used in the United States by pharmaceutical companies and other entities involved in the manufacturing and distribution of drugs and biological products. This form is officially known as the “Application to Market a New or Abbreviated New Drug or Biologic for Human Use,” and it is submitted to the U.S. Food and Drug Administration (FDA) as part of the regulatory process for gaining approval to market a new drug or biologic product.

Information in FDA form 356h

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

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

What after submission to 356h form to USFDA?

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

New Updated 356h form:

Important note: 356h form is recently updated. Followings are the key changes found in the 35h form-

CMC) Section

The updated form now incorporates a new section on CMC, providing comprehensive information on the manufacturing and testing of a drug or biologic. This information is crucial for the USFDA so that they can assess a product’s safety and efficacy.

Pre-clinical Studies Section

The updated form now includes a new section on pre-clinical studies that provide more detailed information on the animal studies conducted; it aims at assessing the safety of a drug or biologic. This information plays a key role in the USFDA’s evaluation of the potential risks associated with the product in terms of human use.

Clinical Studies Section

The updated form now includes a new section dedicated to clinical studies that provide detailed information on human studies designed to evaluate the efficacy and safety of a drug or biologic. This information is vital for the USFDA’s benefit-risk assessment of the product in terms of human use.

Changes to the Labeling Section

The updated form includes a new section on labeling that provides exhaustive information on the Instructions for Use (IFU) of a drug or biologic. This information helps patients and healthcare providers understand how to use the product safely and effectively.

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