Tag Archive: marketing application

May 07

New FDA Guidances from April 2012

Here’s a list of the notable guidances released by FDA in April 2012.

Sep 19

FDA Reorganizes Oncology and Hematology Divisions

When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office of Oncology Drug Products into a new office: The Office of Hematology and Oncology Products …

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Jul 14

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Apr 07

Clinical Trials in South Africa 101

South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment for seasonal diseases can be maintained when the seasons change in the northern hemisphere. Trials …

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Mar 14

2010 New Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.

While the list isn’t long, a few new products stand out to me.

Nov 19

Download the Slides from the Data Quality and Integrity Webinar

Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success!  For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for details on our upcoming webinars! Related articles: Introduction to Good Clinical Practice Webinar Slides (ask-cato.com) …

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Nov 05

Data Quality and Integrity: From Clinical Monitoring to Marketing Approval

At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.”  The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist from our office in Montreal, Canada.

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Oct 18

RAPS Preconference Workshop – EU Regulatory Affairs Essentials

Image via Wikipedia The 2010 RAPS Annual Conference and Exhibition will be from Sunday, 24 October to Wednesday, 27 October at the McEnery Convention Center in San Jose, CA.  While  the “main event” kicks off on Monday, 25 October at 8:30 AM, you should make sure to be in town on Sunday, 24 October to …

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Jul 08

OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)

There are no foreign lands.  It is the traveler only who is foreign. – Robert Louis Stevenson Global.  That’s one of the buzz words/ideas that has gripped modern drug development.  In particular, there is a notion that foreign countries represent some unblemished Eden where clinical trials can be run cheaper and faster than in the …

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May 11

Switching from Paper to eCTD Submissions

Despite the many advantages of eCTD submissions, many smaller companies may still be reluctant to take the leap.  Concerns over the costs of implementing an eCTD publishing system and the lack of in-house expertise are often the primary stumbling blocks.  However, these concerns shouldn’t prevent you from moving forward.  An experienced partner with a proven …

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