From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 08:03:38 -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: May 23, 2008 |
The following new items were added to the CDRH web pages on May 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |  |  |
| Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. | | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 08:34:21 -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. FDA Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations This conference will be held on June 4-5, 2008, in Washington, D.C. http://www.ispe.org/cs/root/education_and_training/events/2008_washington_conferences/fda_cosponsored_event_regulatory_perspectives_on_hot_topics_regulatory_trends_and_observations
2. The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the Food and Drug Administration announced in the Federal Register of May 12, 2008, a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009. The public meeting will be held on June 5 & 6, 2008, in Silver Spring, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-10513.pdf
3. An updated Center for Drug Evaluation and Research Organizational Chart: http://www.fda.gov/cder/cderorg/cder-all.pdf
4. The slides from the presentations at the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop on April 29, 2008, are available at this website: http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
5. List of Current Guidance Documents from the Center from Drug Research and Evaluation: http://www.fda.gov/cder/guidance/CompList042008.pdf
6. Information and slides from the presentations on the workshop Marketed Unapproved Drugs Meeting. http://www.fda.gov/cder/drug/unapproved_drugs/presendations/default.htm
7. To obtain timely information about the Small Business Innovation program you can subscribe to the National Institute's SBIR/STTR LISTSERV. http://grants.nih.gov/grants/funding/listserv.htm
8. The 10th Annual National Institute of Health's Small Business Innovation Research Conference will be held on July 22-23, 2008, in Atlanta, Georgia. Nearly $650M is available this year exclusively for small businesses to perform innovative research and R&D in the biomedical/behavioral sciences http://grants.nih.gov/grants/funding/sbirconf2008/index.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 15:40:19 -0500 (CDT)
Subject: CFSAN Constituent Update
* 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 *
May 23, 2008
FDA Posts Revised Questions and Answers on Acrylamide
The U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has updated the Qs & As on acrylamide with new information related to acrylamide in foods, including adding consumer information on optional ways to reduce acrylamide levels in certain foods.
Acrylamide is a substance that forms in certain foods during some high-temperature cooking practices, such as frying and baking. Acrylamide causes cancer in laboratory animals at high doses, and is therefore a potential human carcinogen. Since the discovery of acrylamide in food in 2002, FDA has initiated a broad range of surveillance and research activities related to acrylamide.
In 2003, FDA posted Qs &As on acrylamide on its website, including the dietary message "to eat a balanced diet, choosing a variety of foods that are low in trans fat and saturated fat, and rich in high-fiber grains, fruits, and vegetables." In 2004, in the Action Plan for Acrylamide in Food, FDA announced its intention to "develop and revise consumer messages about dietary choices and cooking methods, as additional knowledge is gained about acrylamide in food." Given advances in knowledge about ways to mitigate acrylamide in food and FDA's stated intention to revise consumer messages as more knowledge becomes available, FDA has updated its Qs & As on acrylamide to include limited consumer information on acrylamide reduction. This information covers storage of potatoes before cooking, cooking practices for potato products and toasted bread, and dietary intake.
FDA is providing this information for consumers who are looking for optional ways to reduce acrylamide. FDA's best advice for acrylamide and eating is that consumers adopt a healthy eating plan, consistent with the Dietary Guidelines for Americans, that emphasizes fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products; includes lean meats, poultry, fish, beans, eggs, and nuts; and is low in saturated fats, trans fats, cholesterol, salt (sodium) and added sugars. FDA is waiting for completion of new toxicology research that is underway before considering whether new consumer advice on acrylamide is needed.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 23 May 2008 19:04:04 -0500 (CDT)
Subject: FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
Fri, 23 May 2008 18:32:00 -0500
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.
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