Pediatric study for a combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-03 15:53  – Posting: # 21197
Views: 164

Hi John
In principle there is a need for a PIP for all new drug products except generics so also for fixed dose combination (FDC) products, especially if the individual references' dosages are applicable to adolescent and are commonly used together. I am not talking about PK studies but efficacy(!). The fact that the new FDC will have a new dosing interval does not make any difference. Of course you can apply for a PIP-waiver but what would be the arguments? Why should the new product be kept from children? Just saving time and money will not convince PDCO.

Kind regards and have a nice day
Dr_Dan

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