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 21, 2023 | Regulatory
Introduction The Common Technical Document, CTD is a globally recognized format for the submission of drug applications to several regulatory authorities. Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human...
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... by inpharmedia | Aug 15, 2023 | Blog, Product Development, Regulatory
Solvent – A substance, majorly liquid capable of dissolving or diluting other substances to form a solution. Generally, several solvents are used in the manufacturing of drug substance, excipients and drug products as a routine practice. The solvents are used to...
