FDA asks federal judge to wait until 2076 to fully release Covid vaccine data

Re:FDA asks federal judge to wait until 2076 to fully releas... by gumby on Wednesday November 17, 2021 @11:49PM (#29262073)

Having done an FDA submission myself I am actually amazed at how short this time period would be.

In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions.

Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII.

TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.

[ Parent | on HN ]

Re:FDA asks federal judge to wait until 2076 to fully releas... by l8rpeace on Thursday November 18, 2021 @12:39AM (#29262308)

Right but now those submissions are (mostly) electronic since the advent of eCTD (which has been in the works since 2002): https://www.fda.gov/drugs/electronic-regulatory-submission-a...

[ Parent | on HN ]

Re:FDA asks federal judge to wait until 2076 to fully releas... by gumby on Thursday November 18, 2021 @08:26AM (#29265100)

My point was merely to give an idea of the sheer size of an application in a way that TB would not.

Every FOIA request is screened by humans, which can result in false positives and negatives. So could a machine-screened result. Would people be comfortable with an automated screener, which, while hard to do with classified info, would conceptually be possible with FDA records (from either food or drug side). The records are quite free form.

I’m in favor of these records being public except perhaps some proprietary process data. Of course it will be used by people who don’t understand it for wild attacks.

[ Parent | on HN ]