The FDA Review Process is a critical regulatory mechanism ensuring the safety and efficacy of drugs, biologics, and medical devices before they reach the market. It involves a thorough evaluation of clinical trial data, manufacturing processes, and labeling to protect public health.

FDA Review Process

Critical regulatory mechanism

Safety and efficacy of drugs

Biologics are complex, large-molecule drugs derived from living cells used to treat various medical conditions, including cancers, autoimmune disorders, and chronic diseases. They are distinct from traditional small-molecule drugs due to their size, complexity, and method of production, requiring specialized manufacturing processes and regulatory considerations.

Biologics

Medical devices are instruments, machines, implants, or related articles used to diagnose, prevent, or treat diseases and other medical conditions without primarily relying on chemical action within or on the body. They range from simple tools like thermometers to complex machinery like MRI machines, and their development and regulation are critical to ensuring safety and efficacy in healthcare.

Medical Devices

Clinical trial data encompasses the information collected during the research process to evaluate the safety and efficacy of medical, surgical, or behavioral interventions. This data is crucial for regulatory approval, guiding clinical practice, and advancing medical knowledge.

Clinical Trial Data

Manufacturing processes are the methods and techniques used to transform raw materials into finished goods, involving a series of steps such as machining, assembling, and quality control. These processes are critical to optimizing production efficiency, ensuring product quality, and minimizing costs in industrial operations.

Manufacturing Processes

Labeling involves assigning descriptive or categorical tags to data or objects, facilitating organization, retrieval, and analysis. It is a fundamental process in machine learning, data management, and communication, serving as a bridge between raw data and meaningful interpretation.

Labeling

Public health is a discipline focused on protecting and improving the health of populations through organized efforts and informed choices of society, organizations, communities, and individuals. It encompasses a wide range of activities, from disease prevention and health promotion to policy-making and research, aimed at ensuring conditions in which people can be healthy.

Concepts

Relevant Degrees

Your Lessons