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Fda 2915 Form

Fda 2915 Form

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Instructions and help about Fda 2915 Form

what does non FDA approved mean I get this a lot than n Sora so let me clarify just because a medication isn't FD approved for a particular indication doesn't restrict us from utilizing it when deemed therapeutically beneficial for instance in anesthesiology we frequently administer not FD approved medications such as isobaric bacan or racan for spinal anesthesia or IV dexamethasone for post-operative pain management none of this is FD approved but this this is what we refer to as off label use getting FDA approval is resource intensive and expensive and for that reason many Farm companies will not pursue FDA registration if they perceive that clinicians are already using these medications for unapproved uses it's a calculated business decision as clinicians it doesn't really greatly influence our practice but the manufacturers cannot promote these drugs for unapproved indications now you're in the loop

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