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Re: kayak_wench post# 375635

Tuesday, 11/15/2022 2:05:48 PM

Tuesday, November 15, 2022 2:05:48 PM

Post# of 401756

Nasrat just stated that it is no big deal to pull a drug off the discontinued list. That it takes at most a couple of weeks. He also explained why it is a good decision to make in many cases.

Do you want to continue to argue that you know more than even him?




I have a day job, so I haven't listened to the CC. As a matter of fact, I don't find them to be a very reliable source of accurate information, so I don't make any effort, but I will eventually get around to reading it. I stand by every fact I previously posted. As I indicated, he might be right about an ANDA that was just recently approved and just recently discontinued. Just about anything else, *any* kind of change, any significant length of time, will require a supplement, and a supplement will involve back and forth with FDA. If the company is lucky, they'll get away with a CBE-30 but frequently a PAS is required, which is a significantly longer, more involved process. The FDA decides if a PAS is required, not the company, and approval is needed before marketing the drug. That's as simple as I can make it. Feel free to dispute any of those specific facts.

And, yes, I most definitely do, about a lot of things, apparently. Thanks for asking.

.

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