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 3, 2025 | Approvals, Blog, Regulatory
The FDA granted 50 new drug approvals in the year 2024 with several first-in-class, novel therapies and pathbreaking innovations spanning key therapy areas like oncology, gene therapy, immunology, hematology and cardiology. The U.S. Food and Drug Administration (FDA)... 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 | Nov 27, 2023 | Approvals, Regulatory
The U.S Food and Drug Administration (FDA) approved OGSIVEO (nirogacestat) for the treatment of progressive desmoid tumors in adults who require systemic treatment. OGSIVEO is the first drug to be approved for the treatment of patients with desmoid tumors, a rare...
by inpharmedia | Nov 18, 2023 | Blog, Regulatory
The Food and Drug Administration (FDA) is the federal system that approves any drug related to humans. The Agency provides the sufficient information that enables the sponsors and industry to gather the data and requirements from time-to time. These data can be used...
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...
