From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 08:12:10 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: June 27, 2008 |
The following new items were added to the CDRH web pages on June 26, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Brief Summary |  | |
| Federal Register: Hematology and Pathology Devices Panel fo the Medical Devices Advisory Committee; Notice of Meeting. | |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 09:03:27 -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. A FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) will be held on August 4, 2008, in Chicago, Illinois http://www.chpa-info.org/NR/rdonlyres/2E848024-6B23-4AFD-AD42-CC047A700ACB/0/2008_SummerWorkshopReg3.pdf
2. The Office of Compliance has an updated website for contacts: http://www.fda.gov/cder/Offices/Compliance/default.htm#whatwedo
3. An updated organizational chart for CDER is available at this website: http://www.fda.gov/cder/cderorg/cder-all.pdf
4. The Food and Drug Administration in a Federal Register notice of June 19, 2008, proposed that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is issuing this proposed rule because the agency did not receive any data and information on these ingredients in response to the request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA's ongoing review of OTC drug products. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13826.pdf
5. An FDA organizational chart which lists the Centers/Offices including the Office of the Commissioner is available at this website: http://www.fda.gov/opacom/7org.html
6. HHS Secretary Mike Leavitt announced on June 12. 2008, that the Centers for Disease Control and Prevention (CDC) has awarded $12.9 million for the development of low-cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours. http://www.hhs.gov/news/press/2008pres/06/20080612a.html
7. The 10th Annual National Institutes of Health Small Business Innovation Research Conference will be held July 22-23 in Atlanta, GA. http://grants.nih.gov/grants/funding/sbirconf2008/index.htm
8. The National Institutes of Health has a New Investigators Program. Information is available at this website: http://grants.nih.gov/grants/new_investigators/index.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 16:09:52 -0500 (CDT)
Subject: FDA Data Standards Update - Terminology Update - UNIIs
Greetings,
The FDA Data Standards Council's website was updated Friday, June 27, 2008, to include an update to the list of Unique Ingredient Identifiers (UNIIs).
Hyperlinks to the updated list of UNIIs can be found on either of these web pages:
Substance Registration System - Unique Ingredient Identifier: http://www.fda.gov/oc/datacouncil/SRS.htm
Structured Product Labeling Resources: http://www.fda.gov/oc/datacouncil/spl.html
Lonnie Smith
Project Manager
Food and Drug Administration
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