From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Jul 2008 07:43:53 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 11, 2008 |
The following new items were added to the CDRH web pages on July 10, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Circulatory System Devices Panel Advisory Meeting, December 7-8, 2006 - Minutes |  | |
| Circulatory System Devices Panel Advisory Meeting, June 27, 2007 - Minutes | | |
| Circulatory System Devices Panel Advisory Meeting, March 1-2, 2007 - Minutes | | |
| FDA Approves New Genetic Test for Patients with Breast Cancer | | |
| Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Condoms | |  |
| Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves | | |
| Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Transcripts | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Jul 2008 09:17:25 -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. FDA Revises Process for Responding to Drug Applications. The U.S. Food and Drug Administration has announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application .http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15608.pdf.
2. FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices 2008. A workshop on the latest developments concerning quality initiatives for pharmaceutical compliance. August 4, 2008, Chicago, Illinois. http://www.chpa-info.org/ChpaPortal/Meetings/SummerWorkshops/
3. The Food and Drug Administration announced in a Federal Registrer notice of July 2, 2008, that the agency is seeking volunteers from pharmaceutical companies to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality by design and risk management in pharmaceutical manufacturing. The purpose of the pilot program is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. This pilot will focus on products reviewed by FDA's Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER). This pilot program will assist FDA in developing guidance for industry on quality by design and risk management in pharmaceutical manufacturing. The pilot is open to original submissions of and supplements to biologic license applications (BLA) or new drug applications (NDA) reviewed by OBP. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-14999.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. A MAPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A new MAPP was issued on June 23, 2008, regarding . NDAs and BLAs: Communication to Applicants of Planned Review Timelines. This MAPP establishes procedures for informing applicants of the planned review timeline, including the goal dates for discussion of labeling and postmarketing study requirements (PMRs) and commitments (PMCs), for original new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER). http://www.fda.gov/cder/mapp/6010.8.pdf
6. A recent guidance was issued on Bioequivalence Recommendations for Specific Products. http://www.fda.gov/cder/guidance/6772dft.pdf and http://www.fda.gov/cder/guidance/bioequivalence/default.htm.
7. Authorized Generic Drug. An "authorized generic drug" is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug. List of Authorized Generic Drugs. http://www.fda.gov/cder/ogd/AuthorizedGenerics.htm
8. The Parenteral Drug Association and FDA will sponsor a conference, Pharmaceutical Ingredient Supply Chain Conference. : The Conference is a program that will provide information regarding guidance and regulations from various regions, including North America, Europe and Asia. Regulatory and industry representatives from today’s leading organizations, including the World Health Organization and USP, who will share their perspectives and solutions regarding:
In ensuring the quality and integrity of pharmaceutical ingredients Regulations and guidance on GMPs and GDPs
The role of quality systems in supply chain operations Industry practices from the perspectives of API manufacturers,
Excipient manufacturers, drug product manufacturers, and distributors of these materials Opportunities for global cooperation,
Collaboration and harmonization
9. FDA Critical Path Transporter Workshop. Leading scientists from academia, the FDA and industry will present and lead discussion on the current status of the rapidly emerging field of drug transporters, the clinical relevance of drug uptake and efflux transporters, and the application of in vitro and in vivo tools to drug discovery and development. Participants will be encouraged to join discussions on best practices and future directions. The workshop will culminate in the generation of a White Paper. http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17183&eventType=Meeting
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
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 Revises Process for Responding to Drug Applications. The U.S. Food and Drug Administration has announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application .http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15608.pdf.
2. FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices 2008. A workshop on the latest developments concerning quality initiatives for pharmaceutical compliance. August 4, 2008, Chicago, Illinois. http://www.chpa-info.org/ChpaPortal/Meetings/SummerWorkshops/
3. The Food and Drug Administration announced in a Federal Registrer notice of July 2, 2008, that the agency is seeking volunteers from pharmaceutical companies to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality by design and risk management in pharmaceutical manufacturing. The purpose of the pilot program is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. This pilot will focus on products reviewed by FDA's Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER). This pilot program will assist FDA in developing guidance for industry on quality by design and risk management in pharmaceutical manufacturing. The pilot is open to original submissions of and supplements to biologic license applications (BLA) or new drug applications (NDA) reviewed by OBP. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-14999.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. A MAPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A new MAPP was issued on June 23, 2008, regarding . NDAs and BLAs: Communication to Applicants of Planned Review Timelines. This MAPP establishes procedures for informing applicants of the planned review timeline, including the goal dates for discussion of labeling and postmarketing study requirements (PMRs) and commitments (PMCs), for original new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER). http://www.fda.gov/cder/mapp/6010.8.pdf
6. A recent guidance was issued on Bioequivalence Recommendations for Specific Products. http://www.fda.gov/cder/guidance/6772dft.pdf and http://www.fda.gov/cder/guidance/bioequivalence/default.htm.
7. Authorized Generic Drug. An "authorized generic drug" is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug. List of Authorized Generic Drugs. http://www.fda.gov/cder/ogd/AuthorizedGenerics.htm
8. The Parenteral Drug Association and FDA will sponsor a conference, Pharmaceutical Ingredient Supply Chain Conference. : The Conference is a program that will provide information regarding guidance and regulations from various regions, including North America, Europe and Asia. Regulatory and industry representatives from today’s leading organizations, including the World Health Organization and USP, who will share their perspectives and solutions regarding:
In ensuring the quality and integrity of pharmaceutical ingredients Regulations and guidance on GMPs and GDPs
The role of quality systems in supply chain operations Industry practices from the perspectives of API manufacturers,
Excipient manufacturers, drug product manufacturers, and distributors of these materials Opportunities for global cooperation,
Collaboration and harmonization
9. FDA Critical Path Transporter Workshop. Leading scientists from academia, the FDA and industry will present and lead discussion on the current status of the rapidly emerging field of drug transporters, the clinical relevance of drug uptake and efflux transporters, and the application of in vitro and in vivo tools to drug discovery and development. Participants will be encouraged to join discussions on best practices and future directions. The workshop will culminate in the generation of a White Paper. http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=17183&eventType=Meeting
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, 11 Jul 2008 10:02:31 -0500 (CDT)
Subject: Resolved Drug Shortage: Digoxin oral tablets
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Resolved Drug Shortage: Digoxin oral tablets
Fri, 11 Jul 2008 09:35:00 -0500
See website for more information about this resolved shortage.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Jul 2008 11:02:47 -0500 (CDT)
Subject: Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk
Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk
Fri, 11 Jul 2008 10:02:00 -0500
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Jul 2008 14:34:40 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing
Posted: 7/11/2008
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Jul 2008 14:48:57 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Corrected Link
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing
Posted: 7/11/2008
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 12 Jul 2008 15:35:18 -0500 (CDT)
Subject: Recent Device Approvals: Medtronic® Attain StarFix™ Model 4195 Lead
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Medtronic® Attain StarFix™ Model 4195 Lead has recently been posted to the FDA website, and is now available.
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