Category Archive: Guest Posts

Jan 14

Hepatitis C Virus (HCV): An Optimistic Future

By Guest Contributor: William T. Lee, Ph.D., R.A.C., Vice President of Regulatory Affairs at Cato Research Events in the last two months have given the hepatitis C virus (HCV) infected patient community an optimistic outlook for the new year. Foremost is the FDA approval of Solvadi (sofosbuvir), a HCV NS5b polymerase inhibitor, from Gilead Sciences …

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Sep 07

Transitioning from Paper to eCTD Submissions

A common question that many sponsors ask is, “Can we switch a paper application over to eCTD format?”  The short answer is, “Yes.”  For a more detailed explanation, check out my new guest post over at GlobalSubmit’s blog, The eCTD Summit, where I discuss the complete process for converting an IND, NDA, or BLA from …

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Jun 30

Clinical Study Reports to STFs

Module 5 - No STF

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

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Jan 27

Top Reasons to Adopt eCTD Viewing Software

The audience for the eCTD viewer at a drug company ranges from a few users to hundreds or even thousands, depending on the size of the company. Essentially, anyone who writes content, communicates with the FDA, or creates a submission should be using eCTD viewing software. And yet, despite the many advantages and increased global adoption of eCTD submissions, there are still questions and concerns around implementation, in particular among the smaller IND companies.

May 14

Advice from the FDA, Part 2: Making Your eCTD Submission Reviewer-Friendly

Cato’s Director of Regulatory Operations, Evan Richardson, authored a guest blog post featured on PharmPro.com today.  PharmPro.com is the website for Pharmaceutical Processing magazine, offering a wealth of  information on products, technologies and applications for pharmaceutical and biopharmaceutical professionals. Evan’s post, “Advice from the FDA, Part 2: Making Your eCTD Submission Reviewer-Friendly,” offers practical advice …

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Apr 08

Advice from the FDA, Part 1: Technical Errors to Avoid in Your eCTD Submissions

Cato’s Director of Regulatory Operations, Evan Richardson, authored a guest blog post featured on PharmPro.com today.  PharmPro.com is the website for Pharmaceutical Processing magazine, offering a wealth of  information on products, technologies and applications for pharmaceutical and biopharmaceutical professionals. Evan’s post, “Advice from the FDA, Part 1: Technical Errors to Avoid in Your eCTD Submissions,” …

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