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BioInvestor3

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BioInvestor3

Re: ziploc_1 post# 385145

Thursday, 08/04/2022 7:02:46 AM

Thursday, August 04, 2022 7:02:46 AM

Post# of 426487
Zip, you know I'm starting to wonder if KM knows what the hell he's talking about.

FDC (fixed-dose combinations) and co-packaged products (combination packs) are 2 distinct terms.
All I have heard was KM use the term FDC which is clearly defined by the FDA as 2 or more drugs combined into a single dosage form, it will be a single pill.
Now in the cc he mentions blister packs which I never heard him mention before, this implies he's talking about a co-packaged product.
Did he use both those terms (FDC and blister pack) in a single sentence?

FDA has regulations regarding NDA approvals for combo products and they are different whether it is a FDC or a co-packaged product.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4607470/
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