FDA BLA review process and significance of Friday
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(Total Views: 1161)
Posted On: 07/09/2020 8:41:50 PM
FDA BLA review process and significance of Friday July 10
The FDA timeline is 60 days to review the BLA submission to determine if application is sufficiently complete to allow a substantive review. At the end of this process the FDA makes a "determination" to file the application (Ya!), or to refuse to file due to an issue like deficiencies in the application. At day 60 the FDA has 14 days to inform the applicant of the determination in writing by issuing a PDUFA letter, aka the Day 74 letter. Based on the April 27 file date Friday July 10 is day 74.
A few points to note:
1 - The determination should also state if the review will be a "standard" (10 months) or a "priority" (6 months) review as CYDY has requested a priority, aka expedited, review. Note, this would be 6 months or 10 months from the filing date which was on or around April 27 2020. Be aware these time intervals are targets that FDA aims to meet 90% of the time. As a drug this complex could require a F2F mid-cycle review meeting with FDA.
2 - Keep in perspective Covid could impact the FDA "timeline" for the BLA acceptance and the overall review but we hope not!
The FDA process is explained here:
https://www.fda.gov/media/99140/download
The FDA timeline is 60 days to review the BLA submission to determine if application is sufficiently complete to allow a substantive review. At the end of this process the FDA makes a "determination" to file the application (Ya!), or to refuse to file due to an issue like deficiencies in the application. At day 60 the FDA has 14 days to inform the applicant of the determination in writing by issuing a PDUFA letter, aka the Day 74 letter. Based on the April 27 file date Friday July 10 is day 74.
A few points to note:
1 - The determination should also state if the review will be a "standard" (10 months) or a "priority" (6 months) review as CYDY has requested a priority, aka expedited, review. Note, this would be 6 months or 10 months from the filing date which was on or around April 27 2020. Be aware these time intervals are targets that FDA aims to meet 90% of the time. As a drug this complex could require a F2F mid-cycle review meeting with FDA.
2 - Keep in perspective Covid could impact the FDA "timeline" for the BLA acceptance and the overall review but we hope not!
The FDA process is explained here:
https://www.fda.gov/media/99140/download
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