by inpharmedia | Feb 9, 2025 | Blog, Guidances
Introduction Obesity has become one of the most pressing public health concerns worldwide, with significant implications for individual health and healthcare systems. As a result, the need for effective weight reduction therapies has never been more critical. To... 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...