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Once the NDA is submitted, the FDA assigns a review team, which includes experts in various fields such as medicine, chemistry, and statistics. The team thoroughly examines all the submitted data, including clinical trial results, manufacturing information, and proposed labeling. They will assess the drug's benefits and risks, as well as its potential for misuse or abuse. They might conduct their own independent analyses of the clinical trial data to verify the findings. They will also inspect the manufacturing facilities to ensure the drug is produced according to the highest quality standards. This is to ensure that the drug is consistently safe, effective, and meets all regulatory requirements. The FDA can also request additional information or clarifications from the company. The FDA's review process is meticulous and comprehensive, and the agency will do its utmost to make the right decision based on all the available data. If the FDA determines that the drug meets the necessary criteria, it will issue an approval. This allows the company to market and sell **ITAK-003** in the United States. However, the FDA's work doesn't stop there. The agency will continue to monitor the drug's performance after it hits the market, collecting information on any adverse events and other safety issues. This post-market surveillance helps ensure the drug continues to meet the required safety and effectiveness standards.
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