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...
Mastering the CTD: Harmonized Regulatory Data Submissions
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 Use (ICH), the CTD was introduced to streamline the submission process for pharmaceutical companies and to facilitate a consistent approach to regulatory documentation across multiple regions. The CTD is structured to provide a...
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...
Stability data Requirements for a Marketing Authorization Application
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 as temperature, humidity, and light. As we understood the quality of substance or product is varying in the presence of temperature and humidity over the period of time, any sponsor/applicant needs to provide supporting data and...