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355. (a) (b×. (subsection) (j), (interstate commerce)
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What is fda035-sec 355 - new?
The FDA Form 355 (fda035-sec 355) is used to report new drug application (NDA) in the United States.
Who is required to file fda035-sec 355 - new?
The pharmaceutical company or sponsor who has filed an NDA is required to fill out and file FDA Form 355.
How to fill out fda035-sec 355 - new?
FDA Form 355 can be filled out electronically through the FDA's Electronic Submissions Gateway (ESG) or manually by following the instructions provided on the form.
What is the purpose of fda035-sec 355 - new?
The purpose of FDA Form 355 is to provide information about the new drug being submitted for approval by the FDA.
What information must be reported on fda035-sec 355 - new?
The form requires information such as the drug name, active ingredients, proposed indications, dosage form, and manufacturing information.
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