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FDA issued a clinical hold to sponsor due to higher amount of DLT (Dose Limiting Toxicity) ratio provided in protocol that lead to a significant safety issue to patient if human being is exposed.
1. What are the main steps you as a regulatory expert take in order to prepare a response to Agency with time limits of 3 working days?
2. What information you would include in your response package to justify your position that will fulfil FDA's requirements?
3. What submission format would you use to prepare submission such as, eCTD or Paper.
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