Hi all,

the below might be relevant to the ongoing REACH efforts via OpenTox:

---------- Forwarded message ----------
From: M. Scott Marshall <mscottmarshall at gmail.com>
Date: Wed, Jul 7, 2010 at 9:10 PM
Subject: Re: FDA, CDER Data Standards Plan
To: Susie Stephens <susie.stephens at gmail.com>
Cc: public-semweb-lifesci hcls <public-semweb-lifesci at w3.org>


Hi Susie,

Thanks for identifying this unique opportunity to engage with the FDA
about data standards. I have re-pasted the URL's below for convenience
because I had trouble accessing the versions in your previous message.
I am printing the draft to locate specific issues where HCLS can
contribute comments and suggestions.

1. Federal Register, 17 June 2010, 75(116), 34452-34453,
http://edocket.access.gpo.gov/2010/pdf/2010-14637.pdf
2. FDA, CDER Data Standards Plan (Version 1.0), Posted online 17 June
2010, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf

Cheers,
Scott


On Mon, Jul 5, 2010 at 11:28 AM, Susie Stephens
<susie.stephens at gmail.com> wrote:
> The FDA is announcing the availability for public comment of the draft
> document entitled "CDER Data Standards Plan Version 1.0". The draft plan
> outlines the general approach proposed for development of a comprehensive
> data standards program in the Center for Drug Evaluation and Research
> (CDER). The draft plan identifies key objectives for a data standards
> program at CDER, processes to be developed to ensure successful use of those
> standardized data, and a set of recommended projects beginning this calendar
> year [1, 2].
>
> Please let me know if you would be interested in contributing to
> HCLS reviewing the plan and providing feedback.
>
> Cheers,
> Susie
>
>
>
> 1. Federal Register, 17 June 2010, 75(116), 34452-34453,
> http://edocket.access.gpo.gov/2010/pdf/2010-14637.pdf
>
> 2. FDA, CDER Data Standards Plan (Version 1.0), Posted online 17 June 2010,
> www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf




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Proteochemometrics / Bioclipse Group of Prof. Jarl Wikberg
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