From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 06:41:59 -0500 (CDT)
Subject: CDRH New Update
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 | Date: May 9, 2008 |
The following new items were added to the CDRH web pages on May 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides |  |
| PMA Final Decisions for April 2008 | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 08:15:24 -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.The Food and Drug Administration announced in a Federal Register notice of May 5, 2008, the availability for public comment of the draft drug safety 5-year plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five- Year Plan.'' This plan is intended 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. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9726.pdf
2. The Food and Drug Administration announced in a Federal Register notice of May 5, 2008, the 11th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group. The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive questions and answers, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. The conference will be held on June 11 and 12, 2008, in Irvine, CA. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9728.pdf
3. The Food and Drug Administration announced in a Federal Register notice of April 28, 2008, the agency is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki issued by the World Medical Association, specifically the 1989 version, with a requirement that the studies be conducted in accordance with good clinical practice, including review and approval by an independent ethics committee. The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9200.htm
4. The Food and Drug Administration is co-sponsoring the following event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations on June 2-5, 2008, in Washington, D.C. The sessions will provide a forum for exchange of ideas, and an opportunity to hear about new initiatives, and interface with dozens of regulators. 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
5. The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research announced in a Federal Register notice of April 23, 2008, a public workshop entitled ``Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets.'' The purpose of the public workshop is to solicit information and views from interested persons on best practices and principles for the design and evaluation of pharmacoepidemiologic safety studies using large electronic healthcare data sets. The input from this workshop will be used to develop a draft Guidance to Industry, and to provide consistent review criteria for FDA to use in evaluating protocols and study reports submitted to the agency. The public workshop will be held on Wednesday, May 7, 2008, in Silver Spring, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8772.htm
6. Copies of the The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter are available at these websites: http://www.fda.gov/cder/pdufa/Attachment_A_2008.pdf and http://www.fda.gov/cder/pdufa/Attachment_B_2008.pdf
7. The Drug Master Files are updated at this website: http://www.fda.gov/cder/dmf/index.htm
8. CDER Therapeutic Biologic Products. This list is intended to include all the Center for Drug Evaluation and Research (CDER) user fee billable therapeutic biological products and potencies approved under Section 351 of the Public Health Service Act. The Orange Book includes a section entitled "Drug Products with Approval under Section 505 of the Act Administered by CBER." Included on that list are several products that have been transferred to CDER which would be considered billable also. http://www.fda.gov/cder/biologics/pdufa/billable.pdf
9. The statement of Janet Woodcock, M.D.,Director, Center for Drug Evaluation and Research before the Subcommittee on Health Committee on Energy and Commerce United States House Representatives provides FDA’s progress in responding to the challenges created by drugs for the United States (U.S.) market that are either fully manufactured overseas or that are manufactured in the U.S. but contain foreign components. http://www.fda.gov/ola/2008/fdaglobalact050108.html
10. 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
11. The Small Business Administration's VOICE online chat discussion archive provides topical questions from small businesses and responses from experts on a variety of small business issues. http://www.sba.gov/tools/monthlywebchat/index.html
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, 9 May 2008 09:39:55 -0500 (CDT)
Subject: Drug Information Heparin Update
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement. Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used. There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration. Please see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm.
We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.
In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html. Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 10:26:07 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 11:03:41 -0500 (CDT)
Subject: FDA Approves First Generic Ropinirole
FDA Approves First Generic Ropinirole
Fri, 09 May 2008 10:56:00 -0500
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 14:05:12 -0500 (CDT)
Subject: FDA Approves New Formulation of Coagulation Therapy
FDA Approves New Formulation of Coagulation Therapy
Fri, 09 May 2008 14:23:00 -0500
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
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