3 ms·
After over-regulation of PCR tests leading to the flawed CDC test being the only one available during a critical part of the pandemic, the agency decided to swi
by vikramkr 6y ago
After over-regulation of PCR tests leading to the flawed CDC test being the only one available during a critical part of the pandemic, the agency decided to swing way way way too hard the other way so they couldn't be accused of holding up tests from reaching the market. This whole fiasco has revealed the importance of modernizing the FDA (they still need documents to be sent by CDs in the mail![1]). And, of proactively creating pandemic response protocols. They're a healthcare agency! This is their job! The failure of the federal government has been so profound. At least it'll make a good case study for what not to do...
[1] https://www.washingtonpost.com/investigations/2020/04/03/coronavirus-cdc-test-kits-public-health-labs/?arc404=true https://www.washingtonpost.com/investigations/2020/04/03/cor...
- playingchanges 6y agoI work for a software company serving companies that frequently go through FDA processes. Sometimes our software is replacing literally shipping file cabinets of documents to facilitate those processes. It’s amazing how slow some industries move.
- gumby 6y agoUntil only a few years ago, when you were ready to submit your NDA (new drug application — afterballnthe trials were concluded) you literally sent trucks full of paper to the Agency. There were companies that specialized in making that happen properly — you didn’t just hire a trucking company; a lot of coordination was required. I (well, my company but my name was signed on the documents and I did a lot of work) filed one of the very last paper INDs (beginning of the process before you even do Phase I). Honestly it was cheaper and simpler than purchasing one of the special packages needed to do an electronic filing.