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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 June 2022

US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The June month has around 03 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 April 2022

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