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

世界には7,000種類の希少疾患があり、3億5,000万人もの患者が影響を受けていますが、そのうち承認された治療法があるのはわずか300種類です。このギャップは、希少疾病に苦しむ人々の約95%に影響を与えており、極めて大きなアンメット・メディカル・ニーズ(未充足の医療ニーズ)を示しています。モデリング&シミュレーションのアプローチは、希少疾患の治療薬開発に理想的であるだけでなく、規制当局も推奨しています。