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Posted On: 05/14/2017 1:38:55 PM
Post# of 72446
SLC post:
slcimmuno Member Level Saturday, 05/13/17 09:19:46 AM
Re: loanranger post# 181836
Post # of 181919
End-of-Phase 2 meeting - that's where it'll all be discussed, worked out. I do read the quote cited as a good sign - written comments from FDA acknowledging P will require less vetting as to its safety profile, as is common for 505b2. Those comments were in 2014. Below updated FDA guidance from 2016.
“Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.” (CDER/CBER, 2016)
https://www.fda.gov/downloads/drugs/guidances/ucm291158.pdf
"The lynchpin to the possibility of selective safety data collection appears to be the existence of a robust safety database for the product in question. That is often the case with a product being developed using the 505(b)(2) regulatory pathway. By definition, an application pursuant to Section 505(b)(2) frequently relies on extensive, pre-existing safety data.
The guidance contains further details and conditions, the most important of which is the requirement to develop a plan and reach agreement on the specifics of a selective safety data collection with the relevant FDA review division or divisions at, e.g., the end-of-phase 2 meeting prior to initiation of a Phase 3 study."
http://camargopharma.com/2016/03/additional-5...ollection/
slcimmuno Member Level Saturday, 05/13/17 09:19:46 AM
Re: loanranger post# 181836
Post # of 181919
End-of-Phase 2 meeting - that's where it'll all be discussed, worked out. I do read the quote cited as a good sign - written comments from FDA acknowledging P will require less vetting as to its safety profile, as is common for 505b2. Those comments were in 2014. Below updated FDA guidance from 2016.
“Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.” (CDER/CBER, 2016)
https://www.fda.gov/downloads/drugs/guidances/ucm291158.pdf
"The lynchpin to the possibility of selective safety data collection appears to be the existence of a robust safety database for the product in question. That is often the case with a product being developed using the 505(b)(2) regulatory pathway. By definition, an application pursuant to Section 505(b)(2) frequently relies on extensive, pre-existing safety data.
The guidance contains further details and conditions, the most important of which is the requirement to develop a plan and reach agreement on the specifics of a selective safety data collection with the relevant FDA review division or divisions at, e.g., the end-of-phase 2 meeting prior to initiation of a Phase 3 study."
http://camargopharma.com/2016/03/additional-5...ollection/
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