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US FDA Guidances Published in January 2023

US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The January month has around 06 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and...

US FDA Guidances Published in December 2022

The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The December month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and...

US FDA Guidances Published in November 2022

US FDA and ICH issued a series of guidance’s to assists the sponsor and applicants in the generic drug development. The November month has around 11 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review...
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