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APPROVED JURISDICTIONAL DETERMINATION FORM
U.S. Army Corps of Engineers
This form should be completed by following the instructions provided in Section IV of the JD Form Instructional Guidebook.
SECTION
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What is 402 dmf approved jd?
402 dmf approved jd stands for Drug Master File (DMF) approved by the Food and Drug Administration (FDA) which contains confidential information about the manufacturing processes and facilities of a drug product.
Who is required to file 402 dmf approved jd?
Drug manufacturers and applicants who are seeking approval for a new drug application (NDA) or abbreviated new drug application (ANDA) are required to file 402 dmf approved jd.
How to fill out 402 dmf approved jd?
402 dmf approved jd can be filled out electronically through the Electronic Submissions Gateway (ESG) or manually by submitting a paper application to the FDA.
What is the purpose of 402 dmf approved jd?
The purpose of 402 dmf approved jd is to provide the FDA with detailed information about the manufacturing processes, components, facilities, and controls used in the production of a drug product.
What information must be reported on 402 dmf approved jd?
402 dmf approved jd must include detailed information about the drug product, manufacturing process, facilities, and controls used in the production of the drug.
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