Titanium Dioxide in Pharmaceuticals: Balancing Safety, Science, and Supply Chain Reality
Titanium dioxide (TiO₂) — the whitening agent behind most pharmaceutical coatings — stands at the crossroads of science and regulation. As food bans spread across the EU, the question remains: should TiO₂ stay in medicines? This deep-dive explores its safety, significance, and the future of excipient innovation.
Intellectual Property Rights (IPR) in the Pharmaceutical Industry: A Comprehensive Review
Intellectual Property Rights (IPR) play a crucial role in fostering innovation and protecting the work of creators and inventors. The pharmaceutical industry, in particular, heavily relies on IPR to safeguard its investments in drug development, manufacturing processes, branding, and distribution. As pharmaceutical companies invest substantial amounts in research and development (R&D), it is essential to secure these innovations from unauthorized use. In this article, we will delve into...
FDA Inspection Forms Guide: Understanding Form 482, Form 483, Form 484, and Key Enforcement Actions
Understanding FDA inspection forms is essential for compliance success. This guide explains Forms 482, 483, 484, Warning Letters, and Import Alerts with practical insights and strategies for QA, RA, and manufacturing professionals.
FDA’s Published a revised draft guidance on Obesity and Overweight – A New Era for Weight Reduction Therapies
Introduction Obesity has become one of the most pressing public health concerns worldwide, with significant implications for individual health and healthcare systems. As a result, the need for effective weight reduction therapies has never been more critical. To support the development of safe and effective treatments, the FDA has released Revision 2 of its Draft Guidance on Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction. This updated version builds upon...
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...