Update : 1
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: April 11, 2008 |
The following new items were added to the CDRH web pages on April 10, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A. |  |  |
| FDA & YOU - News for Health Educators and Students - Spring 2008 | | |
| Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Waivers for Conflicts of Interest | | |
| Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 17, 2007 - Minutes | | |
| Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Minutes | |
Update : 2
Subject: Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta (April 10)
Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta (April 10)
Fri, 11 Apr 2008 07:49:00 -0500
Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.
Update : 3
Subject: REQUESTED INFORMATION: NEW ISSUE OF FDA & YOU
The new issue of FDA & YOU is now available at www.fda.gov/cdrh/fdaandyou.
In this issue:
· Get to Know Staph (with optional Lesson Plan)
· Microwave Ovens: What you need to know before you get cooking
· Learn About It Online: Food Allergies
· Calendar of National Health Events
Be on the lookout for the FDA & YOU Customer Satisfaction Survey coming soon! This short survey will give you the chance to tell us what you think about FDA & YOU.
FDA & YOU is an e-newsletter dedicated to providing the latest FDA medical product and health information for teens, parents, and educators.
To recommend the FDA & YOU email service to friends, please forward this email to them or ask them to visit the FDA & YOU homepage to sign up.
Happy reading!
The Editors,
FDA & YOU
Update : 4
Subject: A Guide to Drug Safety Terms at FDA
A Guide to Drug Safety Terms at FDA
Fri, 11 Apr 2008 10:18:00 -0500
This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug.
Update : 5
Subject: Find the Latest Drug Product and Safety Information
Find the Latest Drug Product and Safety Information
Fri, 11 Apr 2008 10:18:00 -0500
Resources for keeping up with the latest drug safety information from FDA.
Update : 6
Subject: Recent Device Approvals: CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D)
Information about the CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D), Models M150, M155, M157, and M159 has recently been posted to the FDA website, and is now available.
Update : 7
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 Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008 The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance will have a public workshop on April 29, 2008. from 8:00 a.m. to 5:00 p.m in Dallas Texas. There is no registration fee. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues. http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
2. Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan--Draft Document.
The purpose of this document is to communicate FDA’s strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program. FDA will use this plan to:
Communicate strategies FDA will follow for using PDUFA IV drug safety resources;
Communicate our current activity and establish measures to report progress; and
Provide FDA leadership and management a foundation for understanding planned PDUFA IV drug safety activities. http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf
3. FDA and Generic Drugs Interactive Forum June 30 – July 1, 2008, Bethesda, Md. This conference will provide information on how to and how not to communicate with the Office of Generic Drugs (OGD). You will also hear from generic industry peers about real life examples of experiences with OGD staff and their suggestions for a better way to communicate. http://www.pharmaconference.com/pharmaceutical_conferences/p_conf_brochures/June06_2008.pdf
4. New Guidance: Pharmacogenetics, Genomic Data and Sample Coding Categories The Food and Drug Administration published a notice in the Federal Register notice of April 8, 2008, regarding a guidance on Parmacogenetics, Genomic Data and Sample Coding Categories. This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. This guidance on definitions is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes. As new scientific knowledge in the discipline of pharmacogenomics and pharmacogenetics emerges, the current guidance will be reviewed and expanded if appropriate. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0199-gdl.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-7237.pdf
5. Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007. The Food and Drug Administration (FDA) published a Federal Register notice on March 27, 2008, notifying holders of certain prescription new drug and biological license applications that they will be deemed to have in effect an approved risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007 (FDAAA). Holders of applications deemed to have in effect an approved REMS are required to submit a proposed REMS to FDA. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
6. Draft Guidance on Genotoxicity Testing and Data Interpretation for PharmaceuticalsIntended for Human Use The Food and Drug Administration published a notice in the Federal Register of March 26, 2008, regarding a guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage. http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1076.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0178-GDL.pdf
7. The remarks by Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs on The FDA Amendments Act: Reauthorization of the FDA.
Food and Drug Law Institute Washington, D.C. March 26, 2008. http://www.fda.gov/oc/speeches/2008/fdli032608.html
8. NLM and ORWH Announce New NIH Web Site Source for Women's Health Research Information A new Web resource providing the latest information on significant topics in women's health research from scientific journals and other peer-reviewed sources is now available through the National Library of Medicine (NLM). The NLM, of the National Institutes of Health (NIH), through its Division of Specialized Information Services, Office of Outreach and Special Populations has partnered with the NIH Office of Research on Women's Health (ORWH) to create this one-stop resource. http://www.nih.gov/news/health/mar2008/od-10.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update : 8
Subject: Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal
Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal
Sat, 12 Apr 2008 13:40:00 -0500
The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809").
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