by inpharmedia | Jan 24, 2024 | Blog, 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 | Dec 18, 2023 | Blog
The Bacterial Endotoxins Test (BET) detects or quantifies endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). Endotoxins are components of gram-negative bacteria’s outer cell... 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
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 | Oct 21, 2023 | Blog
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...
