Topic: FDA Approval of "models"

Return to 2012 Open Space/Unconference discussions

 

Disscussion

Toxicology studies get highly vetted by EPA, OSHA and others. Decisions are made based on perception of best practice.


Everything nowadays being based on EBM (that's what you have to testify to in a malpractice suit) so seems like whether or not FDA approves there is use of the medical literature and could be similar use of published models.

Scribe: lytton

Participants:kuprat, einstein

Disscussion

  • Why not look at other agency model approval process--EPA regulatory decision models is the example--NRC Report
Toxicology studies get highly vetted by EPA, OSHA and others. Decisions are made based on perception of best practice.


Everything nowadays being based on EBM (that's what you have to testify to in a malpractice suit) so seems like whether or not FDA approves there is use of the medical literature and could be similar use of published models.


Scribe: Lou Gross

Participants:

 

Disscussion

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