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... by inpharmedia | Apr 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 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... 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 | Dec 19, 2021 | Blog, Regulatory
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors: Patent Non-patent The patent related exclusivities are part of the discussion and we will learn further in this article. PATENT EXCLUSIVITY & the ORANGE BOOK:... by inpharmedia | Aug 15, 2021 | Blog, Regulatory
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a novel drug molecules and can run concurrently with a patent or not. It prevents the submission or effective approval of generic applications and was designed to...