Specific synergies are in Engage in if you end up picking an individual or firm to deliver each U.S. Agent and eCTD submission companies. In the event the FDA requests more information or clarification on eCTD submission contents, sponsors react by distributing supplemental “lifecycle” sequences. In the case of a foreign sponsor, the individual or firm appointed given that the U.
If FDA is unable to Call a foreign registrant specifically or expeditiously, FDA may possibly supply the information and/or documents to America agent.
The U.S. agent determined will probably be expected to complete an automatic method to substantiate that they've agreed to act given that the U.S. agent. The automated system will forward an electronic mail verification request to your U.S. agent. They will be requested to verify her/his consent to act as a consultant/liaison on behalf of your foreign establishment.
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FDA’s supplying info and/or documents to the United States agent is equivalent to providing the same information and/or files to your foreign registrant.
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S. Agent needs to be physically situated in the United States and can function the main and/or default place of contact amongst FDA and the agency. The responsibilities with the FDA U.S. Agent are defined in 21 CFR 207.69 as follows: