Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 05:41:10 -0500 (CDT)
Subject: CDRH New Update
 | Date: April 24, 2008 |
The following new items were added to the CDRH web pages on April 23, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Agenda, Roster, Briefing, Questions |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 06:13:24 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Product Correction: Hepatitis B Surface Antigen AUSAB EIA - Abbott Laboratories
Posted: 4/24/2008, Notification Date: 4/21/2008
Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc
Posted: 4/24/2008, Notification Date: 4/21/2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 09:06:48 -0500 (CDT)
Subject: FDA Proposes Recommendations for Two Animal Drug Funding Programs
FDA Proposes Recommendations for Two Animal Drug Funding Programs
Thu, 24 Apr 2008 09:04:00 -0500
The U.S. Food and Drug Administration has delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 17:06:09 -0500 (CDT)
Subject: FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
Thu, 24 Apr 2008 17:55:00 -0500
The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 18:05:49 -0500 (CDT)
Subject: FDA Approves Relistor for Opioid-Induced Constipation
FDA Approves Relistor for Opioid-Induced Constipation
Thu, 24 Apr 2008 18:44:00 -0500
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 05:50:37 -0500 (CDT)
Subject: CDRH New Update
| Date: April 25, 2008 |
The following new items were added to the CDRH web pages on April 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
| Summary Information for: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 |
|  |
| Federal Register: Draft Guidance for Industry on Developing Coronary Drug Eluting Stents: Public Workshop. | | |
| Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations. | |
| Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions (Updated 4/24/2008) | | |
| Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting. | | |
| Summary Information for: Talent™ Abdominal Stent Graft System |
| |
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 07:06:39 -0500 (CDT)
Subject: Enforcement Report for April 23, 2008
Enforcement Report for April 23, 2008
Fri, 25 Apr 2008 07:00:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 08:03:12 -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 2008 Small Business Assistance Workshop will be held April, 29, 2008, in Dallas, Texas. Participants from CDER include Kim Colangelo (Office of New Drugs), Walter Ellenberg (Office of Nonprescription Products), John Friel (Office of Training and Communication), Ed Sherwood (Office of Pharmaceutical Science), and Ron Wilson (Small Business Assistance). Participants from the FDA's Office of Regulatory Affairs include Tom Arista, David Arvelo and O.D. Evans who work in the FDA Southwest District and Regional Offices. The Workshop will provide information to small pharmaceutical businesses on FDA's premarket requirements, good manufacturing practices, marketing of OTC and generic drugs, financial incentives for the development of new drug products, and information on FDA's small business assistance program. This Workshop will be the third workshop outside of Washington, D.C. Previous workshops have been in Philadelphia and Kansas City. Two workshops have been in Washington, D.C. co-sponsored with the Small Business Administration. Registration information is available at this website: http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
2. The Food and Drug Administration published a Federal Register notice on April 24, 2008, providing a notice that the agency is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by applicants of approved drug and biological products. The Federal Register notice provides the agency's report on the status of the studies applicants have agreed to or are required to conduct. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9007.pdf
3. The Food and Drug Administration published a Federal Register notice on April 18, 2008, announcing the availability of a draft guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007. The draft guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8349.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0224-GDL.pdf
4. The Food and Drug Administration (FDA) in a Federal Register notice of April 15, 2008, announced a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions, and other pertinent information from interested parties. In addition, interested parties may provide views on which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antimicrobial- resistant bacteria, potentially qualify for available grants and contracts or other development incentives. http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1129.pdf
5. Prescription to OTC switch refers to over-the-counter marketing of a product that was once a prescription drug product for the same indication, strength, dose, duration of use, dosage form, population, and route of administration. This website provides an updated Rx-to-OTC Switch List January 1 through March 31, 2008 http://www.fda.gov/cder/Offices/OTC/rx-to-otc.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 08:10:28 -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 2008 Small Business Assistance Workshop will be held April, 29, 2008, in Dallas, Texas. Participants from CDER include Kim Colangelo (Office of New Drugs), Walter Ellenberg (Office of Nonprescription Products), John Friel (Office of Training and Communication), Ed Sherwood (Office of Pharmaceutical Science), and Ron Wilson (Small Business Assistance). Participants from the FDA's Office of Regulatory Affairs include Tom Arista, David Arvelo and O.D. Evans who work in the FDA Southwest District and Regional Offices. The Workshop will provide information to small pharmaceutical businesses on FDA's premarket requirements, good manufacturing practices, marketing of OTC and generic drugs, financial incentives for the development of new drug products, and information on FDA's small business assistance program. This Workshop will be the third workshop outside of Washington, D.C. Previous workshops have been in Philadelphia and Kansas City. Two workshops have been in Washington, D.C. co-sponsored with the Small Business Administration. Registration information is available at this website: http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
2. The Food and Drug Administration published a Federal Register notice on April 24, 2008, providing a notice that the agency is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by applicants of approved drug and biological products. The Federal Register notice provides the agency's report on the status of the studies applicants have agreed to or are required to conduct. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9007.pdf
3. The Food and Drug Administration published a Federal Register notice on April 18, 2008, announcing the availability of a draft guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/ Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007. The draft guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8349.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0224-GDL.pdf
4. The Food and Drug Administration (FDA) in a Federal Register notice of April 15, 2008, announced a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions, and other pertinent information from interested parties. In addition, interested parties may provide views on which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antimicrobial- resistant bacteria, potentially qualify for available grants and contracts or other development incentives. http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1129.pdf
5. Prescription to OTC switch refers to over-the-counter marketing of a product that was once a prescription drug product for the same indication, strength, dose, duration of use, dosage form, population, and route of administration. This website provides an updated Rx-to-OTC Switch List January 1 through March 31, 2008 http://www.fda.gov/cder/Offices/OTC/rx-to-otc.htm
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 10:20:56 -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: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 4/25/2008
Update: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 14:08:38 -0500 (CDT)
Subject: New Type of Latex Glove Cleared
New Type of Latex Glove Cleared
Fri, 25 Apr 2008 14:04:00 -0500
FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex.
Update: 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Apr 2008 14:14:43 -0500 (CDT)
Subject: Strengthening Beef Safety
Strengthening Beef Safety
Fri, 25 Apr 2008 14:04:00 -0500
An FDA regulation further protects consumers of beef against mad cow disease.
Update: 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 24 Apr 2008 15:53:24 -0500 (CDT)
Subject: MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web
The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm
In January 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
EstroGel 0.06% (estradiol gel)
Herceptin (trastuzumab) Intravenous Infusion
Rituxan (rituximab) Injection For Intravenous Use
Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)
Janumet (sitagliptin/metformin HCl) Tablets
Mycamine (micafungin sodium) For Injection
Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use
Tysabri (natalizumab) Injection For Intravenous Use
WelChol (colesevelam hydrochloride) Tablets
Azactam (aztreonam for injection, USP)
Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use
Chantix (varenicline) Tablets
Cialis (tadalafil) Tablets
E.E.S. (erythromycin ethylsuccinate)
Ery-Ped (erythromycin ethylsuccinate, USP)
Humira (adalimumab) Injection, Solution For Subcutaneous Use
Lunesta (eszopiclone) Tablets
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)
PCE (erythromycin particles in tablets) Dispertab Tablets
Rapamune (sirolimus) Oral Solution and Tablets
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