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...
Guide to FDA Inspection Forms and Notices: 482, 483, 484, Warning Letter, and Import Alert
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring public health and safety by regulating a wide range of products, including food, drugs, medical devices, cosmetics, and more. As part of its enforcement and oversight activities, the FDA conducts inspections, issues forms, and takes corrective actions when violations of regulations are identified. These actions help ensure that companies adhere to the standards that protect consumers. In this article, we will explore...
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...