by inpharmedia | Dec 3, 2022 | Guidances, Regulatory
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... by inpharmedia | May 3, 2022 | Guidances, Regulatory
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...