Topic
regulatory submissions
3 published works
Business and Commercial
Unpacking Averages: Popular Ways to Combine Device Functionality
This month, we’re going to look at a visualization that uses network techniques. Visualizing a network is a matter of nodes and edges. If the network were Facebook, the nodes…
Focus on Regulation
Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects
By Randy Prebula, Philip Katz, David Horowitz, Janice Hogan, Jonathan Kahan
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one…
Focus on Regulation
eCTD Format Required for all Mutual Recognition Procedure Submissions
By Elisabethann Wright, Joanna Mrozinska
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure ("MRP") submissions should be made in electronic Common Technical Document format ("eCTD…