Regulatory Framework and Understanding of Marketing Authorization of Drug - Device Combination Products in US Region

Abstract

The combination product market is typically regarded as having considerable growth potential, as it offers better margins and significant patient improvements. Manufacturers of these types of goods are now facing similar encounters, as well as a need for clarity on matters connected to multiple medication and device requirements, as the combination product guidelines and guidance document change in the United States. The requirements for the medical devices, drugs and biologics are very different. There can be many barriers in innovation and there are many regulatory challenges also. Along with regulatory obstacles, there are a slew of other issues to contend with throughout the development of such medicines. Many elements influence innovation, including patent considerations. MOTIVE FOR THE SELECTION OF THE TOPIC ► While FDA doesn’t control drug pricing, their policies do affect competition in the market. This is the nexus of the current efforts on drug pricing. ► Complex drugs comprise high-cost medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs. These medicines generally have at least one feature that makes them harder to “genericize” under our traditional approaches. As a consequence, these drugs can face less competition. In some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition. ► Drug device combination products are aimed to provide targeted treatment, enable better drug delivery and improve the efficacy of the device and medicine. SCOPE OF THESIS WORK: ► Definition of Complex Generic Drugs ► Definition of Combination Products ► Understanding of different types/classes of Combination Product ► Determination of Regulatory Review Divisions ► Determination of Regulatory Pathways for application Submission (510k, PMA, De-novo, ANDA, NDA) ► Understanding of Regulatory Requirements of various sections of a Combination Drug Product (Labeling, CMC, Clinical, CGMP Compliance) ► Various Case studies elaborating the examples of the Drug/Device Combination products of various class and Route of Administration