What Are Biologics And How Does FDA Regulate Them? - Inside the Executive Branch скачать в хорошем качестве

What Are Biologics And How Does FDA Regulate Them? - Inside the Executive Branch

What Are Biologics And How Does FDA Regulate Them? Have you ever wondered how certain advanced medical treatments are developed and regulated? In this informative video, we'll explain the role of the FDA in overseeing biologics—complex medical products derived from living organisms. We'll start by defining what biologics are and the types of treatments they include, such as vaccines, gene therapies, and monoclonal antibodies. We'll discuss how these products are made using intricate biological processes and why manufacturing controls are essential for safety and effectiveness. Next, we'll explain the FDA’s process for approving biologics, including the submission of detailed data on safety, purity, and efficacy through the Biologics License Application. We’ll also cover the phases of clinical trials involving human participants and how the FDA reviews this data to ensure public health. After approval, the FDA continues to monitor biologics through post-market surveillance, inspecting manufacturing facilities, reviewing adverse event reports, and updating guidelines as needed. In addition, we’ll highlight the importance of FDA guidance on manufacturing standards, labeling, and marketing to maintain high-quality treatment options. Whether you're a healthcare provider, patient, or simply interested in medical regulation, understanding how biologics are developed and overseen is essential. Join us for this detailed overview, and subscribe to our channel for more insights on the executive branch and healthcare regulation. ⬇️ Subscribe to our channel for more valuable insights. 🔗Subscribe: https://www.youtube.com/@InsidetheExe... #Biologics #FDA #MedicalRegulation #Healthcare #Biotech #Pharmaceuticals #MedicalInnovation #PublicHealth #DrugApproval #BiologicsSafety #MedicalResearch #ClinicalTrials #HealthPolicy #RegulatoryAffairs #MedicalTreatments About Us: Welcome to Inside the Executive Branch! Our channel is dedicated to breaking down the key elements of the U.S. Executive Branch. We cover essential topics such as the Role of the President, Presidential Powers, Executive Orders Explained, and the functions of The Cabinet and Federal Agencies.