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Registerregulatory requirement for Injection products [Regulatives / Guidelines]
Dear All,
Please clarify the below query
We are planning to submit a ANDA for USA submission for an injectable solution product meant for subcutaneous route of administration.
The product is a sterile, colorless clear isotonic solution in a glass cartridge which is preassembled into a disposable deliver device (pen).
Please suggest on whether biostudy is required or we can proceed based on biowaiver for such type of products.
Regards
Kotu
Please clarify the below query
We are planning to submit a ANDA for USA submission for an injectable solution product meant for subcutaneous route of administration.
The product is a sterile, colorless clear isotonic solution in a glass cartridge which is preassembled into a disposable deliver device (pen).
Please suggest on whether biostudy is required or we can proceed based on biowaiver for such type of products.
Regards
Kotu
Complete thread:
- regulatory requirement for Injection productsbalakotu 2014-03-18 07:34 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- regulatory requirement for Injection products luvblooms 2014-03-19 05:24
Ing. Helmut Schütz