From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Aug 2008 03:06:32 -0500 (CDT)
Subject: CDRH New Update
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 | Date: August 8, 2008 |
The following new items were added to the CDRH web pages on August 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter |  |  |
| Federal Register: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications | | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Aug 2008 08:56:32 -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 July 29, 2008, the availability of a draft information sheet guidance entitled ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions--Statement of Investigator (Form FDA 1572).'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17305.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf
2. The Food and Drug Administration announced in a Federal Register notice of July 29, 2008, that the agency is requesting comments relevant to the implementation of section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. FDA requests that interested persons submit data, information, and comments that will help provide a context for the agency's decisions on implementation of this provision. To encourage responsive comments, FDA is including a series of questions for interested persons to consider in preparing comments. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17356.pdf
3. The Food and Drug Administration announced in a Federal Register notice of August 1, 2008, the rates for prescription drug user fees for fiscal year (FY) 2009. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (PDUFA IV) (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2009 for application fees for an application requiring clinical data ($1,247,200), for an application not requiring clinical data or a supplement requiring clinical data ($623,600), for establishment fees ($425,600), and for product fees ($71,520). These fees are effective on October 1, 2008, and will remain in effect through September 30, 2009. For applications and supplements that are submitted on or after October 1, 2008, the new fee schedule must be used. Invoices for establishment and product fees for FY 2009 will be issued in August 2008, using the new fee schedule. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17738.pdf
4. The Food and Drug Administration announced in a Federal Register notice of August 4, 2008, the availability of a draft guidance for industry entitled ``Labeling OTC Skin Protectant Drug Products.'' This guidance provides recommendations on how to label over-the-counter (OTC) skin protectant drug products. An OTC skin protectant active ingredient can be combined with another OTC skin protectant active ingredient or OTC external analgesic, first aid antiseptic, or sunscreen active ingredients. Each of these combinations has specific labeling requirements, and therefore labeling of OTC skin protectant drug products is complex. This guidance is designed to clarify the permitted combinations of active ingredients along with the corresponding required labeling. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 3, 2008. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17835.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0387-gdl.pdf
5. The Food and Drug Administration announced in a Federal Register notice of August 5, 2008, the availability of a document entitled‘‘Guidance for Industry: Advisory Committee Meetings—Preparation and Public Availability of Information Given to Advisory Committee Members, This document provides guidance to industry sponsors, applicants, and petitioners who develop, prepare, or submit briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. The guidance announced in this notice finalizes the draft guidance of the same title dated February 2007. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17997.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0425-gdl.pdf
6. The Food and Drug Administration announced in a Federal Register notice of August 5, 2008, the availability of a draft guidance document entitled ``Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings.'' This draft guidance is intended to provide guidance on when FDA should consider referring a matter to an advisory committee. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0417-gdl.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-18002.pdf
7. The Food and Drug Administration announced in a Federal Register notice of August 5, 2008, the availability of a guidance document for FDA advisory committee members and FDA staff entitled ``Voting Procedures for Advisory Committee Meetings.'' This document is intended to provide guidance on advisory committee voting procedures that should be used when votes are taken during advisory committee meetings. It does not define when votes should be taken. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-18001.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0196-gdl.pdf
8. The Food and Drug Administration announced in the Federal Register of August 5, 2008, the availability of a guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees''. This guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA policy in applying the applicable statutory and regulatory requirements. This guidance finalizes the draft guidance of the same title dated March 2007 and replaces the guidance document entitled ``FDA Waiver Criteria 2000.'' http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17998.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0424-gdl.pdf
9. The Food and Drug Administration announced in a Federal Register notice of August 5, 2008, the availability of a guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2007 and FDA's ``Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees'' dated January 2002. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-17999.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2002-D-0094-gdl.pdf
10. The Food and Drug Administration announced in a Federal Register notice of August 7, 2008, the availability of a draft guidance for industry entitled ``Control of Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> ``Residual Solvents,'' which replaced USP General Chapter <467> ``Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This draft guidance reflects FDA's recommendations on how to comply with those USP changes. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-18127.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0413-gdl.pdf
11.The Food and Drug Administration announced in a Federal Register notice of August 7, 2008, a public meeting and a request for comments including available data to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report (the Report) relating to the development of agency guidances. The Report's recommendations covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. In addition to requesting comments in response to the questions in this notice and those that will be discussed at the public meeting, FDA is announcing a request for available data and information on the effects of nanoscale materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight. The public meeting will be held on September 8, 2008, from 8:30 a.m. to 5 p.m. in Rockville, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-18132.pdf
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, 8 Aug 2008 14:02:43 -0500 (CDT)
Subject: CFSAN Constituent Update August 8, 2008
* 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 *
FDA Announces Public Hearing on Food Advisory Labeling
The U.S. Food and Drug Administration (FDA) has scheduled a public hearing on allergen advisory labeling on September 16, 2008, at the FDA Center for Food Safety and Applied Nutrition's Harvey W. Wiley Building in College Park, Maryland. Formal notice of the Hearing published in the Federal Register on August 8, 2008. (FR 73 46302)
FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is likely to be most effective in communicating to consumers the likelihood that an allergen may be present in a food. The agency is also interested in receiving comments about whether consumers find advisory labeling helpful for making food purchasing decisions. This public hearing is the first step in closing existing knowledge gaps in developing our long-term strategy.
The hearing will include presentations by agency officials, invited speakers and members of the public. The Federal Register Notice and information regarding registration are available on the FDA Web site.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Aug 2008 20:02:30 -0500 (CDT)
Subject: FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
Fri, 08 Aug 2008 18:00:00 -0500
The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.
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