Tag Archives: marketing application

Credentialing Developments at Cato Research

In 2014, approximately 20-25 members of the global CATO staff participated in extensive training sessions devoted to Canadian Regulatory Affairs. This effort was led by Amelie Rodrigue-Way, PhD from the Montreal office of CATO Research Ltd. During the last 8 … Continue reading

Posted in Canadian Regulatory Affairs, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Comments Off on Credentialing Developments at Cato Research

New FDA Guidances for May 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed … Continue reading

Posted in Cato Research, Clinical Trials, Drug Development, FDA | Tagged , , , , , , , | Comments Off on New FDA Guidances for May 2015

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of … Continue reading

Posted in Clinical Trials, FDA, Industry News | Tagged , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment

FDASIA, Part 1: The “UFAs”

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part series, we will cover the major changes in FDASIA as follows: Part 1: The … Continue reading

Posted in FDA, Industry News, Regulatory Strategy | Tagged , , , , , , , , , , , , , , , , , , , , | 4 Comments

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, … Continue reading

Posted in FDA, Industry News | Tagged , , , , , , , , , , | 3 Comments