Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 06:45:42 -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.
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Posted: 9/15/2008
FDA Approves Treatment for Rare Neurologic Disease
Posted: 9/15/2008
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 08:13:11 -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 - PLASMALINK
Posted: 9/15/2008, Clearance Date: 9/8/2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 08:32:30 -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
1. Amendment of Regulations: The Food and Drug Administration announced in a Federal Register notice of August 22, 2008, that the agency is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-19572.pdf
2. Public Hearing: The Food and Drug Administration announced in a Federal Register notice of August 25, 2008, a public hearing to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews new drug applications (NDAs) for these ingredients. The public hearing will be held on October 2, 2008, from 8 a.m. to 5 p.m. The public hearing will be held at the Sheraton Washington North Hotel, 4095 Powder Mill Rd., Beltsville, MD 20705. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-19657.pdf
3. Draft Guidance. The Food and Drug Administration announced in a Federal Register notice of August 28, 2008, the availability of a draft guidance for industry entitled ``Integrated Summary of Effectiveness.'' This draft guidance describes how an integrated summary of effectiveness (ISE) should be prepared by industry for new drug applications (NDAs) and biologics license applications (BLAs). This guidance, when final, will supersede section G, Integrated Summary of Effectiveness Data, of the 1988 guidance on ``Format and Content of the Clinical and Statistical Sections of an Application'' (Clin-Stat guidance). This guidance also incorporates the conceptual framework of section 2.7.3, Summary of Clinical Efficacy, from the International Conference on Harmonisation (ICH) guidance for industry ``M4E The CTD --Efficacy.'' This guidance is intended to improve the quality of product applications by describing what efficacy information should be submitted so that FDA can make a regulatory decision on an application. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-19906.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0449-gdl.pdf
4. Request for Comments on Scheduling Changes: The Food and Drug Administration in a Federal Register notice of September 5, 2008, requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing the United States' response to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20564.pdf
5. Product-Specific Bioequivalence Recommendations: The Food and Drug Administration (FDA) announced in a Federal Register notice of September 5, 2008, the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20580.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0369-gdl.pdf
6. Workshop. The Food and Drug Administration Dallas District, in cooperation with the Society of Clinical Research Associates, is sponsoring a workshop on FDA Clinical Trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, November 19, 2008, from 8 a.m. to 5 p.m. and Thursday, November 20, 2008, from 8 a.m. to 5 p.m. The public workshop will be held at the Westin Crown Center, 1 East Pershing Rd., Kansas City, MO. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20730.pdf
7. Amendment of Regulations: The Food and Drug Administration announced in a Federal Register notice of September 8, 2008, that that the agency is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20709.pdf
8. Call for Data--OTC Review. The Food and Drug Administration announced in a Federal Register notice of September 12, 2008, a call-for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations of up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients that are generally recognized as safe and effective (GRASE) and are found in the sunscreen monograph regulations. FDA reviewed a time and extent application (TEA) for ecamsule and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether ecamsule can be generally recognized as safe and effective (GRASE) for its proposed OTC use. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-21291.pdf
9. Guidance for Industry: Individual Product Bioequivalence Recommendations. http://www.fda.gov/cder/guidance/bioequivalence/default.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 10:33:07 -0500 (CDT)
Subject: CDRH New Update
 | Date: September 15, 2008 |
The following new items were added to the CDRH web pages on September 12, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket |  |  |
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 10:48:23 -0500 (CDT)
Subject: FDA Radiological Health Program Update
You are subscribed to FDA Radiological Health Program for U.S. Food & Drug Administration (FDA).
The Electronic Submissions software, CeSub, has a new release that includes 3 new templates:
Form 2579, Report of Assembly for Diagnostic X-Ray systems
Microwave Oven Product Report
Television Product Report
The "Getting Your Product to Market (FAQs)" has been expanded and updated here: http://www.fda.gov/cdrh/radhealth/rademitfaq.html.
This information has recently been updated, and is now available here.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 14:03:53 -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.
SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Posted: 9/15/2008
Substantially Equivalent 510(k) Device - MCS+ 9000 System
Posted: 9/15/2008, Clearance Date: 9/15/2008
Substantially Equivalent 510(k) Device - Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System
Posted: 9/15/2008, Clearance Date: 9/15/2008
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 16:04:29 -0500 (CDT)
Subject: FDA Requires Stronger Fungal Infection Warning for TNF Blockers
FDA Requires Stronger Fungal Infection Warning for TNF Blockers
Mon, 15 Sep 2008 15:14:00 -0500
FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 16:04:34 -0500 (CDT)
Subject: Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12)
Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12)
Mon, 15 Sep 2008 15:38:00 -0500
El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend.
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 16:04:28 -0500 (CDT)
Subject: Health Information Advisory on Infant Formula
Health Information Advisory on Infant Formula
Mon, 15 Sep 2008 15:14:00 -0500
In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 15 Sep 2008 16:04:31 -0500 (CDT)
Subject: Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11)
Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11)
Mon, 15 Sep 2008 15:18:00 -0500
Wegmans Food Markets, Inc. has expanded the voluntary recall of in-store made bagels and bialys first announced on Wednesday, September 10. The recall is now expanded to include Challah bread and in-store baked bagels, bialys and rolls. These products were sold in Wegmans' bakery department between June 19 and September 11, 2008.
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