Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-272

excerpt from attached .

The provision refers to proposed product labeling rather than the suggested final printed labeling because we generally review the latter only after an applicant has addressed any major deficiencies in an application.

Dear Phaedrus,
It appears if the data for the potency assay measures up then we still need to endure final printed labelling approval. Perhaps " stick it in sore spot" will suffice .
Some light reading for your enjoyment attached.


My take is we will get an announcement in about 9 trading days stating the potency assay has been accepted/agreed to and approved. But this will not be a full approval/ nor accelerated as
labelling still to tick off. If I'm right , do you ( someone ) have any idea how long that will take? Two weeks ?

Reg

https://www.federalregister.gov/documents/2008/07/10/E8-15608/applications-for-approval-to-market-a-new-drug-complete-response-letter-amendments-to-unapproved