From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jul 2008 08:09:08 -0500 (CDT)
Subject: CDRH New Update
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 | Date: July 25, 2008 |
The following new items were added to the CDRH web pages on July 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Hematology and Pathology Devices Panel Advisory Meeting, July 18, 2008 - Waivers, Brief Summary, Slides |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jul 2008 08:32:15 -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 of July 17, 2008, the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of February 11, 2004 (69 FR 6788), entitled ``Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16396.pdf
2. The Food and Drug Administration announced in a Federal Register notice of July 15, 2008, that the agency is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, FDA is making available a guidance document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs''. This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01863.html and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16011.pdf
3. The Food and Drug Administration announced in a Federal Register notice of July 15, 2008, the availability of a document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated July 2008. The guidance provides assistance in applying relevant current good manufacturing practice (CGMP) requirements of the Federal Food, Drug, and Cosmetic Act (the act) to the manufacture of most investigational new drugs, including biological drugs, used in phase 1 clinical trials. FDA is issuing this guidance concurrently with a final rule specifying that compliance with FDA's CGMP regulations is not required for most investigational drugs that are manufactured for use in phase 1 clinical trials. Therefore, FDA is recommending the approaches outlined in this guidance for complying with the statutory CGMP requirements in the act. The guidance announced in this notice finalizes the draft guidance entitled ``INDs--Approaches to Complying with CGMP During Phase 1'' dated January 2006. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16002.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-D-0157-gdl.pdf
4. The Food and Drug Administration announced in a Federal Register notice of July 11, 2008, the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDA-recommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15801.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-N-0464-gdl.pdf
5. The Food and Drug Administration announced in a Federal Register notice of July 10, 2008, that the agency is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, the agency will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. The agency is also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, the agency is adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. The agency is taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15608.pdf
6. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals. The Food and Drug Administration on July 17, 2008, announced that the agency is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions unique to the agency’s mission. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01861.html
7. PDA/FDA Joint Regulatory Conference, Sept. 8-12, 2008, Washington, D.C. The Food and Drug Administration announced the Good Manufacturing Practices (GMPs) for the 21st Century initiative in 2002, giving the industry its first glimpse of the future of regulatory oversight for pharmaceutical production. The intent of the original initiative was to offer the industry the necessary tools to provide more post-approval flexibility, making continual improvement less of a regulatory burden, and to promote better self-regulation to improve regulatory compliance status. In the five years that have passed since the announcement, regulatory health authorities and industry have partnered by harmonizing requirements and implementing new systems for assuring and maintaining pharmaceutical quality. The 2008 PDA/FDA Joint Regulatory Conference will provide examples of how these new approaches have been successfully implemented. In addition, the conference will examine what is working well and where the industry and regulatory health authorities still need to work to achieve modernized quality systems. http://www.pda.org/webmodules/webarticles/templates/new_conferences_2008_PDA_FDA.aspx?articleid=1453&zoneid=190
8. PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, Sept. 10-12, 2008, Washington, D.C. This Conference will provide the opportunity to join regulatory and industry representatives from some of today’s leading organizations at the PDA/FDA Pharmaceutical Ingredient Supply Chain Conference to learn about the development of global initiatives to ensure the integrity of the Pharmaceutical Supply Chain. The conference will provide information regarding guidance and regulations from various regions, including North America, Europe and Asia, as the industry moves towards global cooperation and harmonization of Good Distribution Practices (GDPs) and controls pertaining to the Ingredient Supply Chain. This meeting will immediately follow the 2008 PDA/FDA Joint Regulatory Conference http://www.pda.org/webmodules/webarticles/templates/2008_PDA-FDA_Pharmaceutical_Ingredient_Supply_Chain_Conference.aspx?articleid=1803&zoneid=233
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, 25 Jul 2008 12:03:36 -0500 (CDT)
Subject: Publix Issues Recall for No Sugar Added Cherry Pie (July 24)
Publix Issues Recall for No Sugar Added Cherry Pie (July 24)
Fri, 25 Jul 2008 11:52:00 -0500
Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jul 2008 13:06:15 -0500 (CDT)
Subject: Recent Device Approvals: EVOLENCE® Collagen Filler
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the EVOLENCE® Collagen Filler has recently been posted to the FDA website, and is now available.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jul 2008 16:14:13 -0500 (CDT)
Subject: FDA Consumer Education about Medicine
You are subscribed to FDA Consumer Education about Medicine for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
A link to this new checklist has been added to the "Over the Counter Medicine-Tips for Parents" site, http://www.fda.gov/cder/consumerinfo/otc_text.htm#Tips
"Checklist for Choosing Over-the-Counter (OTC) Medicine for Children.” Before you go to the store to choose an over-the-counter medicine for your child, use this checklist to help you gather the information you need. At the store, the checklist will help you pick the right medicine.
http://www.fda.gov/cder/medsinmyhome/MIMH_checklist_children.pdf
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jul 2008 19:03:39 -0500 (CDT)
Subject: U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
Fri, 25 Jul 2008 18:14:00 -0500
The U.S. Food and Drug Administration is advising consumers that jalapeño and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalapeño peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.
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