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FINDS SOP 18NINDS Standard Operating Procedure FINDS SOP 18 SOP Title: Data Management in FINDS Version: 1.2Approval Signature:Digitally signed by Path, Indra (NIH/FINDS) [E] Date: 2022.08.02 21:54:54
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NDA electronic data submission is the process of submitting all relevant data electronically for a New Drug Application (NDA) to the regulatory authorities.
Any pharmaceutical company or sponsor seeking approval for a new drug must file NDA electronic data submission.
NDA electronic data submission can be filled out by entering the required data into the electronic submission system provided by the regulatory authorities.
The purpose of NDA electronic data submission is to provide regulatory authorities with all necessary information and data to evaluate the safety and efficacy of a new drug.
Information such as clinical trial data, manufacturing information, labeling, and safety data must be reported on NDA electronic data submission.
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