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Form BT-1 State Form 43760 (R7/11-05) Indiana Department of Revenue Business Tax Application A separate application is required for each business location. To file this application online, visit:
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What is bt- 1 first draft?
BT-1 first draft is a form that needs to be filled out to provide the initial information about a biologic product to the Biologics License Application (BLA) or New Drug Application (NDA).
Who is required to file bt- 1 first draft?
Any entity planning to develop or manufacture a biologic product and submit a BLA or NDA is required to file BT-1 first draft.
How to fill out bt- 1 first draft?
BT-1 first draft can be filled out electronically using the FDA's electronic submission system.
What is the purpose of bt- 1 first draft?
The purpose of BT-1 first draft is to provide initial information about a biologic product to the FDA for review and assessment.
What information must be reported on bt- 1 first draft?
BT-1 first draft requires information such as product description, manufacturing process, product labeling, and clinical data summary.
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