28 ms·
The FDA is required by the CFR to redact certain things from the publicly available file. The privately available file (IE what they get) is not redacted. You
by DannyBee 5y ago
The FDA is required by the CFR to redact certain things from the publicly available file.
The privately available file (IE what they get) is not redacted.
You are correct that there are complex data management systems managing the trial, but i don't think they can quite meet all the CFR requirements in practice. At least, they couldn't when i used to know a lot more about this.
Neither side is right - the plaintiffs are playing language games in a lot of places to make it seem like this is easy. Even with the management systems, it's not.
Th FDA is playing games in saying thy need to review 330,000 pages (like, tons of them are just trial data and chart results. They are standardized page formats, etc. There will be no additional text or names.)
- Jansen312 5y agoFDA fuck up. There are definitely incriminating evidence in there. FDA is not FBI or CIA. They should have zero ability to redact. The only things they will actively redact will be to cover their ass. 55 years long enough for those that incriminate to die off.
- Marc6919 5y agoThey should have redacted the info when they had advisory Committee's review it to recommend boosters and vaccines for kids. Usually when govt has personal identification, they use numeric identifiers in documents as HIPPA is very strict with personal identification. Proprietary data should be concentrated in specific documents and easily redacted. There is no excuse for what they are doing. I have worked with MEDI-CALand Sicial Security information on several occasions as an auditor and a fraud investigator. They have the resources and much of the proprietary and personal information is already coded in a manner that an outsider would not be able to decipher. 500 pages a month is ludicrous.