FDA to Postpone Major Electronic Initiatives
Dec10

FDA to Postpone Major Electronic Initiatives

The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.

Read More

Educational Webinar Recap: Preparing for the eCTD Mandate

The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, offered greater insight into this topic during a free educational webinar,...

Read More

Free Educational Webinar: Preparing for the eCTD mandate

Presentation Details: The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free...

Read More

RAPS 2012 Attendees Focused on Electronic Submission Mandate

I recently attended the RAPS 2012 annual meeting in Seattle, and had the opportunity to speak with many different regulatory professionals from all over the country. One of the main themes that seemed to be on everyone’s mind was the impending PDUFA V mandate on electronic submissions. Based on the information gathered from the sessions and around the exhibit area, it is clear that there is some trepidation as to how to manage...

Read More
Q&A Regulated Product Submissions (RPS)
Oct09

Q&A Regulated Product Submissions (RPS)

Jason Rock, Chief Technical Officer at GlobalSubmit, offered great insight into the topic of Regulated Product Submissions (RPS) or eCTD version 4.0 during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.

Read More