There are many reasons why new drugs are important, such as new diseases, the development of drug resistance, and our increasing understanding of health conditions allowing treatment of prev… Read More
By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist
Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the ele… Read More
Photo by Scott Graham on UnsplashThis blog is the second part in our “Strategizing for NDA\BLA” series. The first part can be found HERE – “Mind the Gap(s): Early Ide… Read More
This article is inspired by the idea by the exciting breakthrough possibilities arising from fetching data to health economics models in real-time using modern software infrastructure capabi… Read More
Special Interest Guidances/Information
Date Posted
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Huma… Read More
As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The… Read More
Managing product information is quite a task. In the stringent world of life sciences, to do so, manufacturers must follow certain standards and procedures which are aligned to FDA’s r… Read More
Enabling Multi-region submissions, effortlessly
While concluding our recent blog post on the Health Canada and the FDA’s DMF Submission mandates, we’ve realized how difficult and… Read More
CDISC Advantages
CDISC has developed a set of data standards to enhance
data collection, management, analysis, and reporting efficiencies, improve safety monitorin… Read More