|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | CDER 'From Our Perspective' Explores Series of Draft Guidances on Real-World Data, Real-World Evidence Collection and analysis of real-world data (RWD) continue to gain traction in the biomedical community, accompanied by a growing understanding of RWD's strengths and limitations. Increased collection of RWD is leading to the generation of real-world evidence (RWE) that can potentially inform regulatory decisions regarding the safety and effectiveness of medical therapies. Such regulatory decisions include whether to approve the drug, what the drug's indication(s) should be, and what safety protocols (if any) are necessary to ensure safe use of the product. As defined by FDA, RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and RWE is the clinical evidence regarding a medical product's use and potential benefits or risks derived from analysis of RWD. To promote progress in the field and address a congressional mandate, FDA is issuing a series of draft guidances for industry on aspects of RWD and RWE in regulatory decision-making. The agency issued four of these guidances in late 2021 and plans to issue more guidance in the future. The guidances released so far cover topics related to data sources, data standards, and regulatory considerations. In this From Our Perspective, CDER experts discuss how these guidances aim to help drug sponsors, health care providers, patients and the public at large have a greater understanding of how RWD and RWE can fit into the regulatory process. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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