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FDA Issues New PDF Specifications

Evan Richardson — Tue, 03 Jan 2012 16:21:06 +0000

In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at … Continue reading →

Fifth China Medicinal Biotech Forum – Conference Recap

Ask-Cato.com Contributor — Tue, 29 Nov 2011 18:57:55 +0000

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading →

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Evan Richardson — Thu, 10 Nov 2011 20:53:43 +0000

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading →

Project Management for Biotech Companies

Ask-Cato.com Contributor — Wed, 02 Nov 2011 17:56:22 +0000

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading →

Pre-IND Submissions in eCTD Format

Evan Richardson — Tue, 25 Oct 2011 19:46:32 +0000

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND … Continue reading →

New FDA Guidances – September 2011

Ask-Cato.com Contributor — Fri, 14 Oct 2011 14:08:30 +0000

Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading →

Health Canada Increases Acceptance of eCTD Electronic-only Filings

Evan Richardson — Tue, 04 Oct 2011 19:16:17 +0000

Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier … Continue reading →

FDA Reorganizes Oncology and Hematology Divisions

Leo DiNapoli — Mon, 19 Sep 2011 20:25:36 +0000

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 … Continue reading →

August 2011 FDA Guidances

Ask-Cato.com Contributor — Thu, 08 Sep 2011 18:02:38 +0000

Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading →

Transitioning from Paper to eCTD Submissions

Evan Richardson — Wed, 07 Sep 2011 14:50:08 +0000

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 … Continue reading →