[IEEE-bhpjobs] Fwd: [21cfrpart11] 21CRFPart11.com Update

[Esther Lumsdon]

---------- Forwarded message ----------
From: Victoria Lander <landernewsgroup at yahoo.com>
Date: May 10, 2006 2:42 PM
Subject: [21cfrpart11] 21CRFPart11.com Update
To: 21cfrpart11 at yahoogroups.com


Hello All,

Here are the latest updates for www.21CFRPart11.com

New Compliance Resources

1. Public Health, Innovation and Intellectual Property Rights
The Commission on Intellectual Property Rights, Innovation and Public
Health has completed its report. On this page, we present it in six
languages. A copy of the WHO report, "Public Health, Innovation and
Intellectual Property Rights," is online at:
http://www.who.int/intellectualproperty/documents/thereport/en/index.html

2. FDA Publish Critical Path List
The FDA has finally just published the Critical Path Opportunities
List. The Critical Path Initiative is aimed at modernizing medical
product development, so new medical discoveries are brought to
patients faster and at a lower cost.

The Opportunities List outlines an initial 76 projects to bridge the
gap between the quick pace of new biomedical discoveries and the
slower pace at which those discoveries are currently developed into
therapies. The FDA�s press release stated that �Over the next few
weeks, the FDA will identify several priority Critical Path research
opportunities. Some of the projects in the list could be undertaken by
one organization; some will require collaborations coordinated and
supported by the FDA.�

To download a copy of the list, visit:
http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf

3. FDA Moves Forward with e-Submissions
In July of 2004, the FDA announced the adoption of the Clinical Data
Interchange Standards Consortium (CDISC) Study Data Tabulation Model
(SDTM) as a recommended method of submitting clinical trial data to
the agency. Since July, there have been 8 submissions that have used
the SDTM format.

In October 2005 the FDA announced, via the federal register, their
intention of making electronic submission mandatory. The noticed
stated that �FDA is proposing to amend the regulations governing the
format in which clinical study data (CSD) are required to be submitted
for new drug applications (NDAs), biological license applications
(BLAs), and abbreviated new drug applications (ANDAs). The proposal
would revise our regulations to require that CSD submitted for NDAs,
BLAs, and ANDAs, and their supplements and amendments be provided in
an electronic format that FDA can process, review, and archive. The
proposal would also require the use of standardized data structure,
terminology, and code sets to allow for more efficient and
comprehensive review of CSD.�

For more information on CDISC and STDM, visit:
http://www.cdisc.org/news/index.html

4. FDA Release List of Guidance Documents
The FDA's Center for Drug Evaluation and Research (CDER) recently
released a list of guidance documents that it plans to develop during
2006. This document, released annually by CDER, lists the titles of
the guidance documents that CDER intends to release during the coming
year.

The CDER document can be seen at: http://www.fda.gov/cder/guidance/CY06.pdf

If you have any questions or comments regarding the site, feel free to
contact us by email at: part11moderator at gmail.com

Best Regards,

V.A.L.
Moderator, 21 CFR Part 11.com Web Site

34 Maple St.
Milford, MA 01757 USA
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