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US FDA Guidances Published in October 2022

The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The October month has around 09 new/revised guidance under GDUFA and DCAP provisions. The links of the guidance’s are provided below for quick review and...

US FDA Guidances Published in July 2022

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