by inpharmedia | Nov 3, 2022 | Guidances, Regulatory
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... by inpharmedia | Aug 2, 2022 | Guidances, Regulatory
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... by inpharmedia | Jul 2, 2022 | Guidances, Regulatory
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... by inpharmedia | Feb 1, 2022 | Guidances, Regulatory
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...
by inpharmedia | Apr 27, 2021 | Blog, Regulatory
Every new drug must prove to be safe and effective to be approved by any health authorities. The new drug/therapeutic moieties invented are protected by a specific patent that allows the innovator firm or patent holder to enjoy the exclusivity to market the product...
