Types of Applications to register and market a new Drug and Biologic in U.S
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 seeking to introduce new products to the U.S. market must navigate specific application processes based on the nature of their products. Understanding the different types of FDA applications is essential to ensure compliance with...
FDA New Drug Approvals in 2024: Insights into Latest Trends, Milestones, and Innovations
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) plays a critical role in ensuring the safety, efficacy, and quality of medications available to the public. By evaluating rigorous clinical and preclinical data, the FDA safeguards public health while fostering innovation in drug...
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...
Understanding the Bacterial Endotoxin Test: A Critical Step for Ensuring Sterile Product Safety
The Bacterial Endotoxin 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...