(Total Views: 374)
Posted On: 09/23/2020 4:47:41 AM
Post# of 653
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FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions. Generally, the timelines for FDA review and action on a request to issue an EUA will be determined on a case-by-case basis and will depend on factors such as:
https://www.fda.gov/media/135659/download
- The product profile;
- The existence, if any, of pending applications for the product;
- The nature of the emergency, potential emergency, or threat of emergency;
- The organization and completeness of the request submission; and
- The workload of the reviewing Center’s personnel.
https://www.fuw.ch/article/relief-partner-bea...edikament/
charliebee DD
FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions. Generally, the timelines for FDA review and action on a request to issue an EUA will be determined on a case-by-case basis and will depend on factors such as:
https://www.fda.gov/media/135659/download
- The product profile;
- The existence, if any, of pending applications for the product;
- The nature of the emergency, potential emergency, or threat of emergency;
- The organization and completeness of the request submission; and
- The workload of the reviewing Center’s personnel.
https://www.fuw.ch/article/relief-partner-bea...edikament/
charliebee DD
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