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Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?
Nope.Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?
No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.Gotta get an ANDA to *manufacture* a generic.
*Compounding* is a different issue/can of worms.
No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.
Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?
No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.
Also, the PQ office is not as slothful as they used to be about ANDA. Since Ted Sherwood took over that oversight (and he's quite the gung-ho bureaucrat), they've been much better about action dates in case you end up wanting to go that route.
If you want to write a PharmD paper on it, it's a great one if you're going to spend an FDA rotation. It's a highly public (to PhRMA and BIO) issue about the fairness and timeliness of review.
....do you know what "generic drug" means?or if you provide it in a slightly different formulation or dosage that is not commercially available. There's all sorts of funny things with compounding.
....do you know what "generic drug" means?
Yes. And a "slightly different formulation or dosage" is not one.yes... do you?
Yes. And a "slightly different formulation or dosage" is not one.