Tag Archive: submissions

Sep 08 2011

August 2011 FDA Guidances

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 Federal Food, Drug and Cosmetic Act (Draft) Design Considerations for Pivotal Clinical Investigations for Medical …

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Sep 07 2011

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 10 2011

New Guidances from FDA – May 2011

Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (Draft) Financial Disclosure by Clinical …

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Feb 23 2011

Free Webinar – FDA Review Process for eCTD Submissions

Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET.

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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