Tag Archive: guest post

May 05 2011

Diabetes Research Strategic Plan

The media continually alerts us to the epidemic of diabetes in the world.  Diabetes is the seventh leading cause of death.  Worldwide in 2007 there were 246 million people diagnosed with diabetes, and an additional 79 million people are at risk of developing diabetes in the near future.  According to the National Institutes of Health …

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Jan 28 2011

How will Healthcare Reform Impact Your Next Investigator Meeting?

The new Healthcare reform legislation can be debated by Americans for days on end, but tucked in among all of the changes for Medicare beneficiaries, pre-existing conditions, and the effects on small business owners lays a provision that most layman would not even notice. This provision, however, has the attention of US drug and device manufacturers and cannot be ignored.

Jan 27 2011

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.

Jul 09 2010

June 2010 FDA Guidances

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in June 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted CMC Postapproval Manufacturing Changes Reportable in Annual Reports (Draft) 6/24/2010 Frequently …

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May 14 2010

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 2010

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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