Leading Pharmaceutical and Life Sciences Facilities Actively Deploying Sensicast for FDA 21 CFR Part 11 Compliance (Marketwire via Yahoo! Finance)
Sensicast Systems, the world's leading provider of turnkey wireless sensor network systems, today announced it has seen rapidly accelerating demand for its SensiNet(TM) solutions from pharmaceutical labs, drug manufacturers, and bio-test facilities seeking to improve and accelerate the process of FDA 21 CFR Part 11 compliance.

Spinach recall sparks oversight calls (WTHR Indianapolis)
Consumer advocates and some lawmakers say that a Salinas Valley company's recall of spinach because of a salmonella scare shows that the federal government must do more to protect the nation's food supply.

SYSPRO Enhances SYSPRO CRM Software to Facilitate FDA Compliance (Business Wire via Yahoo! Finance)
COSTA MESA, Calif.----SYSPRO, a leading provider of enterprise software, has today announced significant enhancements to the SYSPRO CRM solution. These most recent upgrades are designed to enable manufacturers, such as Medical Device Manufacturers and Food Producers, to more easily comply with FDA regulations in addition to promoting ease-of-use, increased efficiency and added system security.

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Africa: Daily HIV/Aids Report (AllAfrica.com)
allAfrica: African news and information for a global audience

AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II (FinanzNachrichten)
AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").

Read more about FDA Approvals - Africa: Daily HIV/Aids Report (AllAfrica.com) allAfrica: African news and information

GeneSearch? BLN Test Kit
The GeneSearch BLN Test Kit is a qualitative in vitro diagnostic test for the rapid detection of metastases larger than 0.2 mm in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. (See explanation of sentinel lymph node... (Approved: 7/16/2007)

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Krasniy Oktyabr Inc. Recalls Herring of Special Ambassador "7 Uzlov" Due to Possible Health Risk (August7)
The recalled Herring "7 Uzlov" was distributed to retail stores in NYC. The product comes in metal round containers, 1.3 kg, UPC code: 4-60556-000153. It is a product of Russia.

Metz Fresh Announces Voluntary Recall of Spinach (August 28)
The spinach is distributed under the label Metz Fresh, in both retail and food service packages. These include 10 and 16 oz bags as well as 4-2.5 lb. and 4 lb. cartons. The only Metz Fresh product affected is spinach that bears the tracking codes 12208114, 12208214 and 12208314. It was distributed in the continental United States and Canada.

Select Krasdale Gravy Dry Dog Food 5lb Bags Voluntarily Recalled in Five States (August 21)
The pet food is being recalled because it has the potential to be contaminated with Salmonella, which can cause serious infections in dogs and cats, and, if there is cross contamination, in people, especially children, the aged, and people with compromised immune systems.

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Dingell, Stupak look into FDA's plan to outsource 322 jobs (Detroit News)
Michigan Reps. John Dingell and Bart Stupak sent a letter Friday to the FDA, requesting all documents connected with the agency's plan to consider contracting 322 jobs to private companies.

AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II (FinanzNachrichten)
AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").

FDA plan to outsource 322 jobs prompts probe by Mich. reps. (Battle Creek Enquirer)
WASHINGTON Two House Democrats are investigating the Food and Drug Administration s plan to consider outsourcing more than 300 jobs.

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Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs.

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FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President's AIDS Relief Plan
FDA granted tentative approval for nevirapine tablets, indicated for use with other antiretroviral agents for the treatment of HIV-1 infection, and for the pediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine -- the first fixed dose anti-HIV product designed to treat children under the age of 12 years.

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Candela Receives FDA Clearance for Its Serenity(TM) Device for Additional Aesthetic Laser Applications (Business Wire via Yahoo! Finance)
WAYLAND, Mass.----Candela Corporation today announced that it received an additional FDA clearance for the Serenity device using Pneumatic Skin Flattening (PSF) technology. This clearance enables the use of the Serenity device for the reduction of pain during all laser and intense pulse light treatments.

FDA Accepts for Review Complete Response to Approvable Letter for Entereg(R) (alvimopan) for POI (Business Wire via Yahoo! Finance)
EXTON, Pa. & PHILADELPHIA----Adolor Corporation and GlaxoSmithKline announced today that the U. S. Food and Drug Administration has accepted as complete, Adolor's response to the November 2006 New Drug Application approvable letter for Entereg for the management of postoperative ileus .

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FDA rules process examined (Journal and Courier)
The U.S. Food and Drug Administration regulates items for human use that range from eye shadow to bedpans and pacemakers. And navigating the river of federal regulations to bring new products to market isn't easy.

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AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II (FinanzNachrichten)
AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").

Reps. Dingell, Stupak To Probe FDA Plan To Outsource 322 Jobs (Nasdaq)
WASHINGTON (AP)--Two House Democrats are investigating the U.S. Food and Drug Administration's plan to consider outsourcing more than 300 jobs.

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Mars Petcare US, Inc. Recalls Dry Dog Food
The U.S. Food and Drug Administration is alerting consumers that Mars Petcare US, Inc. has recalled two dry dog food products because of the potential contamination with Salmonella Schwarzengrund.

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New birth control may be more reliable (The Post and Courier)
Two new hormonal birth control methods may offer American women better-than-ever efficacy at preventing pregnancy, and a chance to banish monthly menstrual periods. But the methods carry a side effect that women might not want: a big chance of unpredictable spotting. A pill called Lybrel, ...

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Federal Court Issues Permanent Injunction Against Puerto Rico Dairies for Drug Residues Found in Cows
The U.S. Food and Drug Administration is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health.

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Binax Now Malaria Test
The Binax Now Malaria Test is a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. This is the first FDA product cleared for detection and identification of the.. (Approved: 6/13/2007)

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IFS, Inc. Recalls Sandwiches Because of Possible Health Risk (August 10)
These products are in a plastic wrapper and contain the exp. 073007. The items are Buffalo Chicken Sandwich PLU # 3707, Cuban Sandwich PLU # 3795, and Asiago Italian PLU #3770.

Cost Plus World Market Recalls Red, Blue, Green, and Yellow Speckleware Beverage Containers and Glass Water Tank For Potential Lead Exposure Risk (August 3)
Cost Plus World Market announced a voluntary recall of the following consumer products: Red, blue, green, and yellow speckleware beverage containers with SKU numbers 370549, 391163, 378321, 378322; and glass water tank retro w/spout with SKU number 378251.

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FDA Takes Action Against Iowa Dairy for Illegal Drug Residues Found in Cows
The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health.

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AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II (FinanzNachrichten)
AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").

Medical Ventures Begins FDA Submission Process For Metricath Gemini (CCNMatthews via Yahoo! Finance)
RICHMOND, BRITISH COLUMBIA-- - MEDICAL VENTURES CORP. has submitted to the U.S. Food and Drug Administration the first of three modules of a pre-market approval application for coronary use of the Metricath Gemini catheter.

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Dr. John Fara Retires as Chairman, President and CEO of Depomed; Mr. Carl Pelzel Appointed President and CEO (Business Wire via Yahoo! Finance)
MENLO PARK, Calif.----Depomed, Inc. today announced the retirement of Dr. John Fara, the Company's Chairman, President and Chief Executive Officer. Dr. Fara will continue to serve Depomed as a Director and a consultant.

LifeCycle Pharma Appoints Francesca DeMartino as Director, Investor Relations and Corporate Communications (wallstreet:online AG)
LifeCycle Pharma A/S (OMX:LCP), an emerging specialty pharmaceutical company focused on developing

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AGA Medical Corporation Receives FDA And CE Mark Approvals For The AMPLATZER Vascular Plug II (Medical News Today)
AGA Medical Corporation ("AGA") announced that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II"). The AMPLATZER Vascular Plug II expands the AGA family of occlusion devices designed to embolize, or close blood vessel and blood vessel malformations in the peripheral vasculature. [click link for full ...

Andra E. Miller of Biologics Consulting Joins BrainStorm Cell Therapeutics as FDA Consultant (Business Wire via Yahoo! Finance)
NEW YORK & PETACH TIKVAH, Israel----BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell technologies and therapeutics, announced today that in preparation of a scheduled pre-pre-IND meeting discussion with the FDA, the company has retained the services of the Director of Cell and Gene Therapies of the Biologics Consulting Group, Inc., Dr.

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FDA Expands Warning on Eating Raw Oysters from Hood Canal in Washington State
The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an additional part (growing area 5) of the southern tip of Hood Canal in Washington state due to a foodborne illness outbreak caused by Vibrio parahaemolyticus bacteria.

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