Katrina’s Blog™

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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

How consensus data standards enable drug submissions at the FDA

August 23, 2018
| Uncategorized

Good data standards enable the effective sharing and comparison of scientific data. For example, the international drug regulatory agencies use a consensus standard called eCTD to help them receive, process, review, and archive submission data more effectively. Data submitted in a standard format may also be combined across many studies to explore new health and safety questions. As was true for the internet, having a consensus standard also enables the development of innovative tools for capturing, managing, curating, and presenting the data in a scientifically meaningful way. To see more on the FDA’s view, check out this Data Standards in the Drug LifeCycle Infographic.

Text Copyright © 2018 Katrina Rogers

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