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,...

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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...

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Drug Development Costs Rise to $1.3 Billion

The cost of bringing a new drug to market is often cited as $1.3B according to a Tufts University study from several years ago. In this study, the $1.3B estimate is an increase of 60% from the previous estimate of $800M. Much of the cost associated with drug development is attributed to resources invested in drugs that never make it to market. Only one out of 10 drugs that are used as part of a clinical trial will become a marketed...

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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...

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PDUFA V Includes eCTD Mandate for Marketing Applications, Commercial INDs

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 for commercial INDs and...

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