FDA’s New Module 1 is a Bridge to eCTD 4 Blog Post

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a…

D360 Express Scientific Data Informatics Hub Blog Post

D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical research organizations. It provides access, integration, analysis and visualization of scientific data from multiple data sources. D360 Express gets you up and running quickly and affordably.

The Role of a U.S. Agent Blog Post

Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the…

Rare Disease and Orphan Drug Development Blog Post

There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of those suffering from rare diseases, represents a huge unmet medical need. Modeling and simulation approaches are not only ideal for the development of drugs for rare diseases, but are encouraged by regulators.