From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 07:55:17 -0500 (CDT)
Subject: CDER's Small Business Assistance Bulletin
Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via e-mail.
1. Pilot Project. The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test the submission and processing of clinical study data provided electronically in a standardized format. This pilot will test the data extract, validation, and load procedures developed to populate ``Janus,'' the study data repository component of a common, standards- based infrastructure that is being developed jointly by the Food and Drug Administration and the National Cancer Institute to support the exchange of clinical research data. The pilot also will test a new XML (extensible markup language)-based submission format for standardized clinical study data. We anticipate that a successful pilot will enable CDER to routinely receive, process, and store all standardized clinical study data in a data warehouse environment that will enhance the center's capability to manage and review standardized study data. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-19197.pdf
2. International Conference on Harmonization. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. International Conference on Harmonization (ICH) was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.
The Food and Drug Administration recently announced in Federal Register notices the availability of draft guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Attached are the Federal Register notices providing background on the guidances with links to the guidance: (1) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17861.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0386-gdl.pdf (2) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17862.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0396-gdl.pdf (3) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17863.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0398-gdl.pdf (4) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17864.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0399-gdl.pdf (5) http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17865.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0400-gdl.pdf
3. A new enhanced Advisory Committee website is now available. http://www.fda.gov/oc/advisory/
4. A recent speech by Andrew C. vonEschenbach, M.D., Commissioner of the Food and Drug Administration is available at this website. The title of the speech is "The FDA's Blueprint for Change". http://www.fda.gov/oc/speeches/2008/commonwealthclub061008.html
5. PDA/FDA Joint Regulatory Conference, Sept. 8-12, 2008, Washington, D.C. The Food and Drug Administration announced the Good Manufacturing Practices (GMPs) for the 21st Century initiative in 2002, giving the industry its first glimpse of the future of regulatory oversight for pharmaceutical production. The intent of the original initiative was to offer the industry the necessary tools to provide more post-approval flexibility, making continual improvement less of a regulatory burden, and to promote better self-regulation to improve regulatory compliance status. In the five years that have passed since the announcement, regulatory health authorities and industry have partnered by harmonizing requirements and implementing new systems for assuring and maintaining pharmaceutical quality. The 2008 PDA/FDA Joint Regulatory Conference will provide examples of how these new approaches have been successfully implemented. In addition, the conference will examine what is working well and where the industry and regulatory health authorities still need to work to achieve modernized quality systems. http://www.pda.org/webmodules/webarticles/templates/new_conferences_2008_PDA_FDA.aspx?articleid=1453&zoneid=190
6. PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, Sept. 10-12, 2008, Washington, D.C. This Conference will provide the opportunity to join regulatory and industry representatives from some of today’s leading organizations at the PDA/FDA Pharmaceutical Ingredient Supply Chain Conference to learn about the development of global initiatives to ensure the integrity of the Pharmaceutical Supply Chain. The conference will provide information regarding guidance and regulations from various regions, including North America, Europe and Asia, as the industry moves towards global cooperation and harmonization of Good Distribution Practices (GDPs) and controls pertaining to the Ingredient Supply Chain. This meeting will immediately follow the 2008 PDA/FDA Joint Regulatory Conference. http://www.pda.org/webmodules/webarticles/templates/2008_PDA-FDA_Pharmaceutical_Ingredient_Supply_Chain_Conference.aspx?articleid=1803&zoneid=233
7. The FY 2009 Product and Establishment Fee Invoices were mailed Friday, August 15, 2008. Full payment of the invoice is due by October 1, 2008. If you do not receive your invoice by August 25, 2008, please contact Michael Jones or Beverly Friedman at 301-796-3602. http://www.fda.gov/cder/pdufa/default.htm
8. Small Business Administration Answer Desk
1-800-U-ASK-SBA (1-800-827-5722)
Send e-mails to: answerdesk@sba.gov
The Answer Desk is the only national toll-free telephone service providing information to the public on small business problems and concerns; moreover, this service provides general information about SBA programs and other programs available to assist the small business community. A reply to your email message (answerdesk@sba.gov) may take up to five working days (typically Mon - Fri except holidays).
Business Information Assistants are available to speak directly with you between the hours of 9:00 AM and 5:00 PM (East Coast Time) by calling the Answer Desk at 1-800-U-ASK-SBA (1-800-827-5722). Outside of these hours, you may hear a recording of the information 24 hours, seven days a week.
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 08:02:06 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: August 22, 2008 |
The following new items were added to the CDRH web pages on August 21, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Online Registration Now Available) |  | |
| Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment | |  |
| Summary Information for: VIABAHN® Endoprosthesis | |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 10:02:38 -0500 (CDT)
Subject: Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach
Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach
Fri, 22 Aug 2008 09:47:00 -0500
In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 12:02:36 -0500 (CDT)
Subject: FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
Fri, 22 Aug 2008 11:22:00 -0500
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 12:36:31 -0500 (CDT)
Subject: CFSAN Constituent Update August 22, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
August 22, 2008
Web-Based Training Module, "ALERT: Food Defense Awareness"
Now Available in Spanish
The U.S. Food and Drug Administration (FDA) is now offering a Spanish version of its web-based training module, "ALERT: Food Defense Awareness". The English version of this module was released in 2007, as part of the FDA’s new food defense awareness program, ALERT. ALERT identifies key points that industry and businesses can use to raise awareness of food defense issues and decrease the risk of intentional food contamination at various points from farm to table. The module can be used by FDA investigators, other federal, state and local regulatory agencies, and by industry stakeholders, from growers to retail.
For questions regarding the ALERT program or the web-based training module, please contact Marion Allen at marion.allen@fda.hhs.gov or 301-436-1584.
The Best Defense is to Be Prepared. View the ALERT training module and other food defense-related issues at Food Defense and Terrorism.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 13:51:55 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Substantially Equivalent 510(k) Device - Seraclone Control ABO+Rh; Coombscell-E; MLB2
Posted: 8/22/2008, Clearance Date: 7/23/2008
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 14:02:24 -0500 (CDT)
Subject: Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
Fri, 22 Aug 2008 13:43:00 -0500
The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 22 Aug 2008 15:37:15 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Risk Communication is Key
The FDA this Week: Andy's Take -- FDA: Risk Communication is Key
Fri, 22 Aug 2008 18:36:00 -0500
No matter how good FDA's science and our science-based decisions are, if we want to truly protect and promote your health, we must communicate our decisions in a way that you can understand. Because the science is complex and often uncertain, involving risks and benefits, communicating that science – risk communication – is as important and as challenging as any activity FDA undertakes.
My take is that to do this most effectively, we must take full advantage of the science of risk communication - and FDA can do this much better.
Randall Lutter, Ph.D.
Deputy Commissioner for Policy of the Food and Drug Administration
Andy's Take Guest for the Week of August 18
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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