Comments for Ask Cato

Comment on FDA Issues New PDF Specifications by How to Submit a DSUR to an eCTD IND | eCTD Tips

How to Submit a DSUR to an eCTD IND | eCTD Tips — Mon, 23 Jan 2012 16:27:56 +0000

[...] FDA Issues New PDF Specifications (ask-cato.com) Posted in Guidances, Tips and Advice | Tags: Annual Report, DSUR, eCTD, FDA, IND « Multiple eCTD Sequences in One Day? You can leave a response, or trackback from your own site. [...]

Comment on Health Canada Increases Acceptance of eCTD Electronic-only Filings by Pre-IND Submissions in eCTD Format | Ask Cato

Pre-IND Submissions in eCTD Format | Ask Cato — Tue, 25 Oct 2011 19:46:40 +0000

[...] Health Canada Increases Acceptance of eCTD Electronic-only Filings (ask-cato.com) [...]

Comment on Health Canada Increases Acceptance of eCTD Electronic-only Filings by Multiple eCTD Sequences in One Day? | eCTD Tips

Multiple eCTD Sequences in One Day? | eCTD Tips — Mon, 17 Oct 2011 19:56:12 +0000

[...] Health Canada Increases Acceptance of eCTD Electronic-only Filings (ask-cato.com) Posted in Tips and Advice | Tags: CDER, eCTD, ESG, FDA, Information Request Letter, Regulatory Project Manager « Microsoft Office 2010 and PDF Creation Problems You can leave a response, or trackback from your own site. [...]

Comment on August 2011 FDA Guidances by Health Canada Increases Acceptance of eCTD Electronic-only Filings | Ask Cato

Tue, 04 Oct 2011 19:16:25 +0000

[...] August 2011 FDA Guidances (ask-cato.com) [...]

Comment on Transitioning from Paper to eCTD Submissions by Evan Richardson

Evan Richardson — Fri, 23 Sep 2011 19:35:40 +0000

Thanks for this info Missy! This is different than what I was told about a year ago, so it’s nice to hear that FDA is updating their policies to make work easier for us publishers.

Comment on Transitioning from Paper to eCTD Submissions by Missy Fussell - Allegro Solutions Inc

Missy Fussell - Allegro Solutions Inc — Fri, 23 Sep 2011 17:02:02 +0000

I recently emailed to the E-Subs Group at FDA regarding converting a client’s existing paper IND to electronic and received the response below, one important thing to note is that you can use the next sequential serial number as the SN, it does not have to be SN0000 for existing INDs and is not hard coded. Using the process described below allows for sequence and serial numbers to remain in sync. I just did a successful submission to FDA 2 days ago using the process Valerie describes below assigning the SN as 0004 for the first electronic submission.
Response from Valerie Gooding E-Subs Group at FDA:
“You don’t need to resubmit any previously submitted information when you convert to eCTD and you can use m1.4.4 to provide a PDF of the IND’s paper TOC or other cross reference information.
When you transition to eCTD, you can use sequence 0000 or any other sequence number. For INDs, usually companies use the same as their serial number so the serial and sequence numbers are in sync. Below is some additional information which recommends that the first eCTD submission be intentionally coded as a first level submission type.
It’s recommended that your first eCTD sequence be identified as a general correspondence submission in the cover letter and FDA Form stating the application will be submitted in eCTD format from this date forward and then intentionally code the us-regional.xml as the original application so you can list it as a related sequence and it will establish the hierarchal structure as well as keep the amendments grouped together.
The FDA form should list the submission type as General Correspondence (Other). The bold print on the top of the cover letter should say the correct submission type (General Correspondence, Amendment, etc.) In the body or at the end of the cover letter, you could state something similar to the following:
“As per the advice received from Office of Business Informatics, this eCTD submission sequence is intentionally being coded as an original application in the us-regional.xml and serves as a first-level submission type in the Electronic Common Technical Document (eCTD) format. This eCTD sequence is intentionally being submitted as the original application to establish the eCTD hierarchal structure and will allow second-level submission types such as amendments and resubmissions to be related to it” .
Establishing hierarchal structure is recommended when a first level submission type is in progress, so you can relate amendments to that first level submission type.”

Comment on Divisive Devices or UFC 510(k): FDA Meets IOM by Precious Life

Precious Life — Wed, 24 Aug 2011 19:38:19 +0000

Just take a look at the TMJ Implant Disaster that continues to this day! My implant was a failure from the start…I never had a chance!
Regulations don’t work because they can never be enforced.
http://www.fairwarning.org/2010/12/jaw-implants-backed-by-flawed-research-conflicts-of-interest-investigation-finds/

Comment on FDA Enforcement of New IND and BA/BE Safety Reporting Requirements by Dr Purav

Dr Purav — Fri, 17 Jun 2011 10:49:31 +0000

Hi,
I would like to know that in this guidance, wether FDA has elaborated or explained on the safety reporting requirements of any BE study with clinical endpoints? Basically these studies are clinical trials between the innovator and generic product. Should this be considered as IND studies or traditional BA-BE study?

Comment on India: The next up and coming location to run clinical trials? by Jacquie Mardell

Jacquie Mardell — Tue, 03 May 2011 18:04:57 +0000

India has been an important component of global clinical trial strategy for some years now and in many ways is a stronger choice than China, which gets much more attention these days. However sponsors who go to India simply for cost reductions are missing the point. The regulatory pathway through the DCGI’s office requires sponsors and CROs to bring their A game, and sponsors must take special care for vulnerable populations.

Comment on Clinical Trials in South Africa 101 by Jeremy Wilkerson

Jeremy Wilkerson — Sat, 16 Apr 2011 22:58:36 +0000

You should also do your due diligence before working with Clinical Investigator Site. Here are a couple of points you should ask to make sure they have quality systems in place.
1) How many studies have they participated in
2) Do they have Clinical Trials SOPs in place
3)How type of training program they have in place