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 | 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 | Approvals, Blog, Regulatory
The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA. LEQEMBI ITEMDESCRIPTIONNDA/BLA Number:761269Applicant/Holder:EISAI INCAPI:LecanemabDosage... 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...