A so-called 351 application.

Draft guidance draft guidance provides details on of a risk-based 'totality-of-the - evidence'approach that the FDA is planning to assess submitted data and information to the bio - similarity between the proposed product and the reference product use. The FDA has outlined in its draft guidelines that it recommends a step - by-step approach in the development of bio - similar products.. Scientific considerations in demonstrating bio - similar to a reference product: The draft guidelines The draft guidance is to prove to assist companies with the FDA that a proposed therapeutic protein product is designed - similar to to a reference product for the purpose of filing an application, a so-called '351 'application.

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