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US FDA Guidances Published in May 2022

The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The May 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...

US FDA Guidances Published in March 2022

US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The March month has around 02 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 January 2022

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 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review...
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