FDA Guidance – Revising ANDA Labeling Following Revision of the RLD Labeling
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 approval date. The guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This...
Bacterial Endotoxins Test – A Critical Parameter for Sterile Product
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 membrane. If these endotoxins are injected into humans or animals, they can cause multiple biological effects. The presence of endotoxins in raw materials and parenteral products is likely due to the ubiquitous nature of gram-negative...
FDA Approved OGSIVEO as the FIRST and ONLY treatment for Desmoid Tumours
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 subtype of soft tissue sarcomas. OGSIVEO is a first-in-class medication developed by SPRINGWORKS THERAPEUTICS INC. OGSIVEO granted a Priority Review, FDA Fast Track and Breakthrough Therapy designations for the subject indication by...
US FDA DATABASES – A PRIME TOOL FOR REGULATORY INTELLIGENCE
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 as a regulatory intelligence tool to understand the agency’s current thinking and meet the applicable requirements and keep focus on the competitor analysis. There are several databases in the FDA to track the necessary information...
FDA recommendations on Quality Considerations for Topical Ophthalmic Drug Products
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 evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. Use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage...