5 ms·

What is alarming and missing from the BI story is that there were two documents issued by the FDA - one which covers the issues mentioned (more of pre-market an

What is alarming and missing from the BI story is that there were two documents issued by the FDA - one which covers the issues mentioned (more of pre-market and conduct) the second one listed here: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469395.pdf http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-org... is equally damming. This one deals with the requisite post-market aspects (surveillance, complaint remediation, etc). For a Medical Tech. start-up to fail on post-market surveillance is in-excusable. Move Fast & Break Things should not apply to people's health and medications. There is something very wrong when a company with that much cash fails BOTH in pre & post market situations.

eitally 11y ago
Absolutely agree. Any established CRO or pharma treats surveillance and [especially] post-marketing product safety & adverse event reporting as mission critical activities. The kind where, if you don't do it properly and follow the rules, you get shut down. (My wife has worked in this area for the past ˜15 years, in both clinical & post-marketing environments. It's serious business.)
stephengillie 11y ago
For those of us who are not doctors, but play one on the internet: https://en.m.wikipedia.org/wiki/Postmarketing_surveillance https://en.m.wikipedia.org/wiki/Postmarketing_surveillance
Alex3917 11y ago
A large percentage of companies don't do their post-market surveillance, and the FDA has never even once revoked approval because of it. The whole FDA approval process is basically a scam.
- refurb 11y ago
  Uhhh... that's not correct at all.[1] Are you confusing it with post-marketing commitments to run additional clinical trials? That's not the same thing as post-marketing surveillance. [1]http://www.fiercepharma.com/story/roche-overlooks-80000-adverse-reaction-complaints/2012-06-21 http://www.fiercepharma.com/story/roche-overlooks-80000-adve...
  - Alex3917 11y ago
    "Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study." "Under the current system, the FDA has the authority to revoke approval of some drugs for which Phase IV commitments have not been honored. This authority has never been invoked." http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.citizen.org/hrg1520 http://www.citizen.org/hrg1520
    - OopsCriticality 11y ago
      The Phases apply to drugs, not devices.

eitally 11y ago

Absolutely agree. Any established CRO or pharma treats surveillance and [especially] post-marketing product safety & adverse event reporting as mission critical activities. The kind where, if you don't do it properly and follow the rules, you get shut down. (My wife has worked in this area for the past ˜15 years, in both clinical & post-marketing environments. It's serious business.)

stephengillie 11y ago

For those of us who are not doctors, but play one on the internet: https://en.m.wikipedia.org/wiki/Postmarketing_surveillance https://en.m.wikipedia.org/wiki/Postmarketing_surveillance

Alex3917 11y ago

A large percentage of companies don't do their post-market surveillance, and the FDA has never even once revoked approval because of it. The whole FDA approval process is basically a scam.

refurb 11y ago
Uhhh... that's not correct at all.[1] Are you confusing it with post-marketing commitments to run additional clinical trials? That's not the same thing as post-marketing surveillance. [1]http://www.fiercepharma.com/story/roche-overlooks-80000-adverse-reaction-complaints/2012-06-21 http://www.fiercepharma.com/story/roche-overlooks-80000-adve...
- Alex3917 11y ago
  "Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study." "Under the current system, the FDA has the authority to revoke approval of some drugs for which Phase IV commitments have not been honored. This authority has never been invoked." http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/ http://www.citizen.org/hrg1520 http://www.citizen.org/hrg1520
  - OopsCriticality 11y ago
    The Phases apply to drugs, not devices.