Between coughing and sputtering today I engaged in
Post# of 5066
Posted On: 09/11/2013 8:51:51 PM
Between coughing and sputtering today I engaged in a 30 minute or so conversation with a person from Division of Disclosure and Oversight Management, Office of Communication Outreach and Development, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. I received the call in response to a FOI request I submitted on 6 September.
During the course of this call I was advised what I already knew: that any information regarding an IND application is confidential and that no details whatsoever of the application or the ongoing process will be provided prior to what the FDA ultimately discloses after a final determination or a withdraw of the application is concluded.
So, why did I make this request if I know without a doubt that I will be told that they ain't talking? A few reasons, actually:
------To hear it directly from the source (that is how I roll).
------To receive in writing any rules or subsets that pertain exactly to the confidentiality rule
----- To see if anytime during the course of the request being processed I am told "we have no idea what you're talking about...what is HemaXellerate?"
----- To document how long the process takes from the time I submit the request to the time I am denied my appeal of the original denial (all of which will take much longer than 30 days I have absolutely no doubt).
-----
Although I was told exactly what I knew I would be with respect to the application, I was very much tickled by the knowledge I did receive (read between the lines).
You can refer to my post over yonder to the FDA rule that clearly stipulates that ALL information pertaining to an IND application is confidential.
I will update with the FDA's decisions on my request as I receive them. Goodness knows I do hope that the process is completed for the HemaXellerate application before then.
Please pay no mind to "guesses" that there has been a denial. Or, people who claim to have corresponded with people that "know" the details of the application (i.e., that the application definitely includes the Orphan Drug classification). These messages are a bunch of poppycock.
Did it look like shorts were maybe covering today????
BMSN
During the course of this call I was advised what I already knew: that any information regarding an IND application is confidential and that no details whatsoever of the application or the ongoing process will be provided prior to what the FDA ultimately discloses after a final determination or a withdraw of the application is concluded.
So, why did I make this request if I know without a doubt that I will be told that they ain't talking? A few reasons, actually:
------To hear it directly from the source (that is how I roll).
------To receive in writing any rules or subsets that pertain exactly to the confidentiality rule
----- To see if anytime during the course of the request being processed I am told "we have no idea what you're talking about...what is HemaXellerate?"
----- To document how long the process takes from the time I submit the request to the time I am denied my appeal of the original denial (all of which will take much longer than 30 days I have absolutely no doubt).
-----
Although I was told exactly what I knew I would be with respect to the application, I was very much tickled by the knowledge I did receive (read between the lines).
You can refer to my post over yonder to the FDA rule that clearly stipulates that ALL information pertaining to an IND application is confidential.
I will update with the FDA's decisions on my request as I receive them. Goodness knows I do hope that the process is completed for the HemaXellerate application before then.
Please pay no mind to "guesses" that there has been a denial. Or, people who claim to have corresponded with people that "know" the details of the application (i.e., that the application definitely includes the Orphan Drug classification). These messages are a bunch of poppycock.
Did it look like shorts were maybe covering today????
BMSN
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