Posted On: 09/08/2016 6:44:29 PM
Post# of 30035
I received an email from the FDA today. I asked them yesterday what the status of the ODD and RFDD applications were and also what the time frame is to respond to a RPDD application. Their response:
"Unfortunately, we cannot share any information with you about the status of these designation requests. You will need to consult with the regulatory affairs personnel at Amarantus Bioscience. FDA only corresponds with the sponsor’s point of contact and you are not listed as the POC for this record. The statutory timeframe to respond to a Rare Pediatric Disease request is 60 days"
I didn't expect them to give out any info, but clearly they responded to AMBS' application some time ago - it was submitted in Dec, but AMBS has never mentioned anything regarding either the ODD or the RPDD since submitting the application. I am guessing the FDA came back and asked for a missing part of the application or they are in discussions with them.
"Unfortunately, we cannot share any information with you about the status of these designation requests. You will need to consult with the regulatory affairs personnel at Amarantus Bioscience. FDA only corresponds with the sponsor’s point of contact and you are not listed as the POC for this record. The statutory timeframe to respond to a Rare Pediatric Disease request is 60 days"
I didn't expect them to give out any info, but clearly they responded to AMBS' application some time ago - it was submitted in Dec, but AMBS has never mentioned anything regarding either the ODD or the RPDD since submitting the application. I am guessing the FDA came back and asked for a missing part of the application or they are in discussions with them.
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