by inpharmedia | Jan 8, 2025 | Blog, Regulatory
The United States Food and Drug Administration (FDA) plays a crucial role in regulating the approval and marketing of drugs, biologics, and a wide range of other products, including food, pharmaceuticals, medical devices, and cosmetics. Companies and researchers... 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 | Sep 9, 2023 | Blog, Product Development, Regulatory
Any drug substance or drug product has to maintain the same quality, safety and efficacy throughout the lifecycle of a product. Generally, the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such... 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...
