FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

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Understand Obstetric & Gynecology Trends in the Use of Birth Control Devices (Business Wire via Yahoo! Finance)
DUBLIN, Ireland----Research and Markets has announced the addition of the "Contraceptive Devices: Where Are They Now? Understanding Obstetric & Gynecology Trends in the Use of Birth Control Devices" report to their offering.

Birth Control and Family Planning (New York Times)
In-Depth From A.D.A.M. Oral Contraception Oral contraceptives are available only by prescription and come in either a combination of estrogen and progestin or progestin alone. Many brands of each form are available.

Implanon a convenient contraceptive (Washington State University Daily Evergreen)
Implanted contraceptive a safe and effective option that works three ways to prevent pregnancy.

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CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159
The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies. (Approved: 3/13/2008)

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S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)
The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".

Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label.

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FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

Read more about FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory

FDA Clears Test to Help Doctors Manage Heart Transplant Patients
The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

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Fitch: FDA Could Reshape Tobacco Industry (Manufacturing.net)
If legislation passes to give the FDA the authority the regulate the tobacco industry, it could reshape the industry's competitive landscape, Fitch Ratings said.

Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH (Centre Daily Times)
Alquest, Inc. - the leading contract research organization (CRO) specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA).

Read more about Fitch: FDA Could Reshape Tobacco Industry (Manufacturing.net) If legislation passes

MSN successfully completes US FDA, EU GMP audits (PharmaBiz)
The Hyderabad-based MSN Laboratories Limited, the flagship company of the Rs 150 crore MSN Group of Companies, has successfully completed US FDA and EU GMP audits.

Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH (Business Wire via Yahoo! Finance)
MINNEAPOLIS----Alquest, Inc. - the leading contract research organization specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S.

FDA Grants IND For Pro-Pharmaceuticals' DAVANAT To Treat Breast Cancer Patient (Medical News Today)
Pro-Pharmaceuticals, Inc. (Amex: PRW), today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky.

Read more about FDA Approvals - MSN successfully completes US FDA, EU GMP audits (PharmaBiz) The

Instrumentation Laboratory Receives FDA Clearance To Expand The Intended Use Of HemosIL(R) D-Dimer Assay (Medical News Today)
Instrumentation Laboratory (IL) announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to expand the intended use for the HemosIL D-Dimer assay to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonar

Chelsea's Droxidopa receives US FDA Fast Track status for NOH (PharmaBiz)
US Food and Drug Administration (FDA) has granted Fast Track designation to Chelsea Therapeutics International's Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).

Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH (Centre Daily Times)
Alquest, Inc. - the leading contract research organization (CRO) specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA).

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FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

Read more about FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley

FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

Read more about FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory

Bioxel Pharma: 2008 Second Quarter Results (CCNMatthews via Yahoo! Finance)
QUEBEC CITY, QUEBEC-- - Bioxel Pharma Inc. , a leading manufacturer of taxane active pharmaceutical ingredients and developer of targeted oncology drugs, today announced its results for the second quarter ended June 30, 2008.

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Dutch Company Factory CRO Chooses US-based AmeriStart to Promote Its Medical Device Clinical Services to the American ... (Centre Daily Times)
AmeriStart announced today that it has signed a sales, marketing, and business development services contract with Factory CRO, a leading international clinical research organization that specializes in conducting medical device studies for FDA and EU approvals. AmeriStart will promote Factory CRO's considerable clinical research capabilities in the growing North American medical device market.

FDA Approves First Bone Marrow Stimulator To Treat Immune-Related Low Platelet Counts (Medical News Today)
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

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FDA Clears Test to Help Doctors Manage Heart Transplant Patients
The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

Read more about FDA Clears Test to Help Doctors Manage Heart Transplant Patients

Birth Control (New York Times)
Confronting medical issues can be difficult, and because research changes so often, confusing. Here are some questions you may not think to ask your doctor, along with notes on why they re important.

Birth Control (New York Times)
Dr. Daniel R. Mishell Jr., is professor of obstetrics and gynecology at the Keck School of Medicine of the University of Southern California . Since 1970, he has been editor of the journal Contraception . Dr. Mishell introduced the first pregnancy test to the United States that did not involve the killing of rabbits, a technique still in use today.

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Talent™ Abdominal Stent Graft System
The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent? Abdominal Stent Graft System is made of a fabric... (Approved: 4/15/2008)

Read more about Talent™ Abdominal Stent Graft System The Talent™ Abdominal Stent Graft

FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
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.

Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12)
Hop Lee Trading Co. Inc. is recalling Flower brand Dried Sweet Potato because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH (Business Wire via Yahoo! Finance)
MINNEAPOLIS----Alquest, Inc. - the leading contract research organization specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S.

Dutch Company Factory CRO Chooses US-based AmeriStart to Promote Its Medical Device Clinical Services to the American ... (Centre Daily Times)
AmeriStart announced today that it has signed a sales, marketing, and business development services contract with Factory CRO, a leading international clinical research organization that specializes in conducting medical device studies for FDA and EU approvals. AmeriStart will promote Factory CRO's considerable clinical research capabilities in the growing North American medical device market.

Read more about FDA Approvals - Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH

Dutch Company Factory CRO Chooses US-based AmeriStart to Promote Its Medical Device Clinical Services to the American ... (Business Wire via Yahoo! Finance)
CHARLOTTE, N.C.----AmeriStart announced today that it has signed a sales, marketing, and business development services contract with Factory CRO, a leading international clinical research organization that specializes in conducting medical device studies for FDA and EU approvals.

FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral Chronic Total Occlusions (PR Newswire via Yahoo! Finance)
Stereotaxis, Inc. , announced today that it has received regulatory clearance from the U.S. Food and Drug Administration for its magnetically tipped, PowerAssert radiofrequency guidewire to cross chronic total occlusions in the peripheral vasculature.

Read more about FDA Approvals - Dutch Company Factory CRO Chooses US-based AmeriStart to Promote Its

FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley
The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP).

Read more about FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley