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October 13, 2016,
Division of Dockets Management (HFA305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re:Docket No. FDA2016D1703; Draft Guidance for Industry and
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What is fda-d-1703 draft guidance for?
fda-d-1703 draft guidance provides recommendations on how to submit an application for authorization of a medicinal product.
Who is required to file fda-d-1703 draft guidance for?
Manufacturers seeking authorization for a medicinal product must file fda-d-1703 draft guidance.
How to fill out fda-d-1703 draft guidance for?
You can fill out fda-d-1703 draft guidance by following the instructions provided in the guidance document.
What is the purpose of fda-d-1703 draft guidance for?
The purpose of fda-d-1703 draft guidance is to help manufacturers submit a complete and accurate application for authorization of a medicinal product.
What information must be reported on fda-d-1703 draft guidance for?
Information such as product details, manufacturing process, safety data, and efficacy data must be reported on fda-d-1703 draft guidance.
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