Elite Pharmaceuticals Inc (ELTP): Good question rocioyogi.why couldn't the...

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Jimmy Joe

Re: rocioyogi post# 225949

Sunday, 09/04/2016 4:15:36 PM

Sunday, September 04, 2016 4:15:36 PM

Good question rocioyogi.

why couldn't the FDA just include the pamphlet information as a requirement and approve it without the CRL letter ?

One would have to ask the FDA that one. Of course may end up getting a totally different person answering the question than the one who proposed the original in the CRL.
FDA.. the ultimate think tank.

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