Ikonisys Receives FDA Clearance For Non-Invasive, HER-2 Breast Cancer Test (Medical News Today)
Ikonisys, a leading provider of next generation, non-invasive, cell-based diagnostic solutions, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its oncoFISH her2 test.

FDA Statement On Release Of Bisphenol A (BPA) Subcommittee Report (Medical News Today)
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA's draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.

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FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.

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Birth Control Methods Explained (Central Connecticut State University Recorder)
CCSU health services held an open session last Thursday aimed at informing women of the different forms of birth control on the market. The session was held in the Women s Center lounge, located in the Student Center.

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ELA Ovatio CRT-D System
The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate... (Approved: 5/15/2008)

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The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20)
The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10)
Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110 86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product.

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

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FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

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FDA Approves Treatment for Rare Neurologic Disease
The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

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BlueCielo Showcases InnoCielo Meridian Enterprise and FDA Module at 2008 ISPE Annual Meeting (PRWeb via Yahoo! News)
BlueCielo presents compliance with FDA 21 CFR Part 11 regulations with InnoCielo Meridian Enterprise and the FDA Module - October 26-29, 2008, Booth 911 (Mizner Center), Boca Raton Resort & Club, Boca Raton, FL.

DCL Extends Structured Product Labeling (SPL) Services to Meet New FDA Requirements; Support Now Offered for CDER, ... (PRWeb via Yahoo! News)
Data Conversion Laboratory, Inc. (DCL) (www.dclab.com), announced the availability of enhanced Structured Product Labeling (SPL) services to meet the recently announced FDA requirements for SPL submissions of CDER (Human Prescription Drugs), CBER (Biologics), CDRH (Medical Devices), CVM (Veterinary Medicine), and ONP (Over-the-Counter) products.

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UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy For Partial Onset Seizures In Adults (Medical News Today)
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Vimpat (lacosamide), a new antiepileptic drug (AED). Vimpat is for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older.

FDA Warns Bayer About Two Illegal Aspirins (Medical News Today)
The US Food and Drug Administration (FDA) has written warning letters to drug company Bayer HealthCare about two over the counter (OTC) aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the drug

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Supreme Court To Consider Federal Pre-Emption In Wyeth V. Levine Next Week (Medical News Today)
The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27).

FDA should lift stevia import alert, says ABC (Nutraingredients.com)
In the upcoming issue of HerbalGram , ABC s publication, Mark Blumenthal, ABC s founder and executive director, calls FDA s 1991 Import Alert on stevia for use as a food additive "unreasonable and illogical" given the "current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste."

Marck Bioscience eyes US FDA approval, acquisition in US (PharmaBiz)
In an effort to expand its reach in the regulated markets of US and Europe, the Ahmedabad-based Marck Biosciences Ltd, a noted manufacturer and marketer of sterile liquid parenterals, is likely to file for US Food and Drug Administration (FDA) approval for its facility at Kheda in the next six months.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

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FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease.

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FDA Has Accepted For Filing The First Potential Once-a-Day Nasal Antihistamine (Medical News Today)
The New Drug Application (NDA) for a newly formulated higher strength azelastine nasal spray has now been accepted by the Food and Drug Administration (FDA) as complete for substantive review after initial evaluation. "This product has the potential to become the first once-a-day nasal antihistamine in the U.S.

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FDA should lift stevia import alert, says ABC (Nutraingredients.com)
In the upcoming issue of HerbalGram , ABC s publication, Mark Blumenthal, ABC s founder and executive director, calls FDA s 1991 Import Alert on stevia for use as a food additive "unreasonable and illogical" given the "current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste."

Marck Bioscience eyes US FDA approval, acquisition in US (PharmaBiz)
In an effort to expand its reach in the regulated markets of US and Europe, the Ahmedabad-based Marck Biosciences Ltd, a noted manufacturer and marketer of sterile liquid parenterals, is likely to file for US Food and Drug Administration (FDA) approval for its facility at Kheda in the next six months.

A 'Negative' Label For Drug Makers (Forbes)
Clinical studies with inconclusive or immaterial results are too often mischaracterized.

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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.

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2008 Ballot Measures (Hispania News)
Ballot Measure Forum: Amendment 46 - Does it End Discrimination or Threaten Equal Opportunity? Tues., September 30, 6:00pm. Colorado Technical University, 4435 N Chestnut St, Colorado Springs - For information: HankTWatson@aol.com Ballot Measure Forum Amendments 46-48, 52-60 plus Ref L Thurs.,

ACC denied underage-sex data (The Australian)
THE secretive Australian Crime Commission, now using its coercive powers as part of the federal intervention into child sexual abuse in the Northern Territory, is locked in a battle of wills with remote-area doctors and nurses who it believes are under-reporting child abuse.

Birth Control Methods Explained (Central Connecticut State University Recorder)
CCSU health services held an open session last Thursday aimed at informing women of the different forms of birth control on the market. The session was held in the Women s Center lounge, located in the Student Center.

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Akreos Posterior Chamber Intraocular Lens
Akreos posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's... (Approved: 9/5/2008)

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Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8)
The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected.

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

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Spiration, Inc. Receives First FDA Approval for Bronchial Valve (Centre Daily Times)
Spiration, Inc., a developer of novel medical devices designed to benefit patients with acute and chronic conditions of the lung, announced today that the company has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for the use of its minimally invasive IBV(R) Valve System to control prolonged air leaks of the lung, or significant air leaks ...

The FDA Approves Production Process Strategy Of Aplidin(R), New Marine-Derived Anti-Tumor Agent, Proposed By PharmaMar (Medical News Today)
The Food and Drug Administration (FDA) has accepted the proposal made by PharmaMar, of the Zeltia Group for the production process of Aplidin , a new marine-derived anti-tumor agent, in clinical development for the treatment of hematological and solid tumors. The starting materials for the initiation of the production process have also been approved.

FDA should lift stevia import alert, says ABC (Nutraingredients.com)
In the upcoming issue of HerbalGram , ABC s publication, Mark Blumenthal, ABC s founder and executive director, calls FDA s 1991 Import Alert on stevia for use as a food additive "unreasonable and illogical" given the "current scientific and medical information supporting the safety of stevia when consumed in relatively small amounts in foods to give them a sweet taste."

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FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

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