Regulated Product Submissions (RPS)

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… Read more →

DIA EDM and ERS/eCTD Conference Recap

Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations at Ardea… Read more →

Free Educational Webinar:Regulatory Electronic Submissions: eCTD v4 Background and Drivers

Presentation Details: The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during… Read more →

PDUFA V and the Impact on You

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance… Read more →

The Latest on Regulated Product Submission (RPS)

It has been a while since I have updated you on the RPS project. Back in September, I had expressed cautious optimism on being able to bring RPS to vote (ballot) in May 2011. We did not make the May 2011 ballot, thus the ballot is now delayed until September 2011. We did not make the ballot, in my opinion,… Read more →