The RTF may not be so cut and dried.
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Posted On: 09/28/2020 4:31:22 PM
The RTF may not be so cut and dried.
The FDA's 2017 draft of guidance for the issue says that an appeal can be made to have the BLA filed over the protest of the review division (the review division that determined an RTF was necessary). The company has a meeting with the FDA, provides updated info and asks for a file over protest 60 days after the meeting. So no new BLA submission is needed.
It's page 6 section C here:
https://www.fda.gov/media/109758/download
This was a draft of a proposed procedure so I'm not sure if it was implemented, but it's the only such specific outline of what goes on that I could find on the FDA site, and it's still prominently there.
Not sure how much filing over protest would save in the long run on time to approval or how realistic a filing over protest is, it could almost never happen.
The FDA's 2017 draft of guidance for the issue says that an appeal can be made to have the BLA filed over the protest of the review division (the review division that determined an RTF was necessary). The company has a meeting with the FDA, provides updated info and asks for a file over protest 60 days after the meeting. So no new BLA submission is needed.
It's page 6 section C here:
https://www.fda.gov/media/109758/download
This was a draft of a proposed procedure so I'm not sure if it was implemented, but it's the only such specific outline of what goes on that I could find on the FDA site, and it's still prominently there.
Not sure how much filing over protest would save in the long run on time to approval or how realistic a filing over protest is, it could almost never happen.
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