New FDA Guidances – September 2011

Posted on 14 October 2011 by Ask-Cato.com Contributor
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Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson.

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Health Canada Increases Acceptance of eCTD Electronic-only Filings

Posted on 4 October 2011 by Evan Richardson

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 this year), HC will now also accept these submission types:

  • Request for Priority Review Status: New Drug Submissions (PRNDS) and Supplement to a New Drug Submission (PRSNDS)
  • Pre-Submission Meeting Information
  • Drug Identification Number Application (DINA)
  • Drug Identification Number Application – Biologic (DINB)

You should read through the full notice, which includes a significant amount of specific details to assist you in preparing and filing these submissions in eCTD electronic-only format.

It’s also important to note that, despite the use of the term “electronic-only,” a paper cover letter is still required along with the electronic media.  The paper cover letter will no longer be needed once HC has secure electronic transmission of data in place.

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FDA Reorganizes Oncology and Hematology Divisions

Posted on 19 September 2011 by Leo DiNapoli

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 (OHOP).

This reorganization creates four divisions: Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), Division of Hematology Products (DHP), and Division of Hematology Oncology Toxicology (DHOT).  Importantly, DOP1 and DOP2 will handle reviews for both biologics and drugs.

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The FDA also provided the following information on applications that will, or will not, be moving around: Continue reading →

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August 2011 FDA Guidances

Posted on 8 September 2011 by Ask-Cato.com Contributor
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Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson.

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Transitioning from Paper to eCTD Submissions

Posted on 7 September 2011 by Evan Richardson

GlobalSubmitA 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 paper to eCTD format.

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