Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2020-03-09 13:50 (227 d 05:15 ago) – Posting: # 21228
Views: 3,237

Hello ping4santosh,

in addition to what ohlbe has said, I'd like to mention that the guideline does open up for "substitution"; read section 4.2.
Substitution on its own may not be adequate justification for the existence of your FDC (that's the issue with the section Ohlbe quoted), and that's why many companies in your situation will need to prove that the monos are co-prescribed in your target markets (unless they wish to spend trillions on clin. trials to prove some superiority over standard care).
Co-prescribing info, in turn, is "easily" obtained from third party sources but you will also be paying an arm and a leg for that info. You will not find the reports by googling. It may nevertheless be exactly what you need to justify the FDC.

Check also if "initial therapy" applies with your product - section 4.3. I can't determine that from the info you wrote.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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