by inpharmedia | Jan 24, 2024 | Guidances, Regulatory
FDA published a new guidance in support of Drug Competition Action Plan, named “Revising ANDA Labeling Following Revision of the RLD Labeling”, providing the recommendations to tentatively approved ANDAs to help facilitate final approval on the earliest lawful... by inpharmedia | Oct 21, 2023 | Blog, Product Development
The FDA guidance discusses on quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. The guidance specifically discusses on: Approaches to... by inpharmedia | Feb 3, 2023 | 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 06 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and... by inpharmedia | Jan 3, 2023 | Guidances, Regulatory
The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The December month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and... 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...