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IV '*# X H O IV JUN 272014 SR N. 13,HIVOXBIOTEKJNC. F. No. j&IL4cosu 23,Shingle Road. Ranching District, New Taipei City, Taiwan Phone:+886 28511 2668 Fax:4+886 2 8511 2669 5. 510(k) SUMMARY (According
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Visit the official FDA website and navigate to the "IV - Accessdata" section.
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IV - Accessdata FDA is a system used by the Food and Drug Administration to collect and store information related to investigational new drug (IND) applications.
Sponsors or applicants submitting IND applications are required to file information in IV - Accessdata FDA.
To fill out IV - Accessdata FDA, sponsors or applicants must enter all required information relating to their IND application electronically through the FDA's designated system.
The purpose of IV - Accessdata FDA is to provide the FDA with essential information about investigational new drugs, streamline the application process, and facilitate regulatory review.
Information such as the drug's ingredients, manufacturing process, proposed clinical trials, safety data, and labeling information must be reported on IV - Accessdata FDA.
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