FDA Announces Voluntary Withdrawal of Pergolide Products
FDA today announced that manufacturers of pergolide drug products, which are used to treat Parkinson s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients heart valves.

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Schering-Plough to buy Akzo's Organon for $14.5 bln (Reuters via Yahoo! News)
Akzo Nobel said on Monday it was selling its drugs unit Organon BioSciences to Schering-Plough for 11 billion euros ($14.5 billion), dropping plans to float it in a public share offering.

Schering to buy Dutch drug unit (The Record)
Schering-Plough Corp. said Monday it will buy the pharmaceutical division of Netherlands-based health care products maker Akzo Nobel NV for $14.4 billion in cash, in a bid to diversify its product range and strengthen its pipeline of new drugs.

Schering-Plough to buy Akzo's Organon for $14.4 bln (Reuters via Yahoo! News)
Schering-Plough Corp has agreed to buy Akzo Nobel NV's drugs unit Organon BioSciences for 11 billion euros ($14.4 billion) in a bid to gain scale and diversify away from cholesterol medicine.

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FDA Warns Again About Arsenic in Mineral Water
The agency is providing this information again to consumers due to an expansion of the recall initiated by the products' importers and distributors. "Jermuk" water is imported from Armenia and distributed under different labels in California. Five brands of these products have been recalled since March 7.

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Radiesse (P050037)
Radiesse is an injectable calcium hydroxylapatite implant in the form of a gel. (Approved: 12/22/2006)

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FiberChoice Plus Multivitamins Issues Allergy Alert Fish Allergen Not Declared on Label
This recall affects 90 count (16oz.) plastic bottles with the UPC #5714500581, which is located on the side of the bottle in black lettering.

Smith and Nephew Issues Nationwide Recall of RF Denervation Probes Used for the Spine
The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.

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Recall of Pet Foods Manufactured by Menu Foods, Inc.
The products are packaged in cans and pouches under numerous brand names and are marketed nationwide by many pet food retailers including Ahold USA Inc., Kroger Company, Safeway, Wal-Mart Stores, Inc., PetSmart, Inc., and Pet Valu, Inc.

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DOR BioPharma Announces FDA Clearance to Conduct Phase 2 Clinical Trial of orBec(R) for the Prevention of GVHD (RedNova)
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to conduct a Phase 2 clinical trial of orBec(R) for the prevention of Graft-versus-Host disease ("GVHD").

Abbott's Hot Streak Includes News On Crohn's (Investor's Business Daily via Yahoo! News)
The good news keeps coming in bunches for Abbott Laboratories.

DOV Pharmaceutical, Inc. Announces Fourth Quarter and 2006 Year-End Results (PR Newswire via Yahoo! Finance)
DOV Pharmaceutical, Inc. announced today results for the fourth quarter and year ended December 31, 2006.

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Preparing for an FDA Inspection: What To Do When FDA Shows Up At Your Door (Nutraingredients.com)
3/28/2007 - Being prepared for a US Food & Drug Administration (FDA) inspection requires advanced and effective planning and, for nutraceutical companies whose products do not require FDA pre-approval, it may be their first hands on experience with the Agency.

Dry pet food producers also received chemical-tainted supply (USA Today)
The contamination in wet pet food that has injured and killed pets across the country may not have been the pesticide aminopterin but instead, perhaps, a fertilizer called melamine, the Food and Drug Administration now says.

Bioresearch Online Interview With Thom Davis, Pacific BioLabs (BioresearchOnline)
Thom Davis is quality and regulatory compliance manager at Pacific BioLabs. Thom has been performing duties related to quality and regulatory compliance for 30 years in a variety of industries including nuclear power, environmental protection, occupational safety and health, medical devices, pharmaceuticals, and biopharmaceuticals.

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Averion Appoints Glenn E. Deegan Vice President and General Counsel (Business Wire via Yahoo! Finance)
BOSTON----Averion International Corp. , a clinical research organization specializing in oncology, medical devices, dermatology and nephrology, today announced the appointment of Glenn E.

Gunther promotes hunger awareness (The Narrowsburg River Reporter)
MONTICELLO, NY Assemblywoman Aileen Gunther (D-Forestburgh) came to Monticello on Thursday, March 15 to help serve food at the Federation for the Homeless in rcognition of Hunger Awareness Day.

First New Waterborne Aquaculture Drug In 20 Years Approved (Science Daily)
Twelve years of rigorous research by USGS scientists helped lead to the approval by the Food and Drug Administration (FDA) of the first waterborne drug for fish diseases in more than 20 years. The drug, 35 percent PEROX-AID, a product of EKA Chemical, Inc, in Marietta, Ga., was approved recently for use in three diseases of freshwater fish and their eggs that, left untreated, cause significant ...

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FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder
FDA today approved Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death. Soliris is classified as an Orphan Drug and is a new molecular entity containing an ingredient not previously marketed in the United States.

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Advancements in birth control give women more options (Burlington County Times)
Several FDA approvals during the past few months are providing more birth control options for women and offering protection against viruses that can cause cervical cancer and genital warts.

Business news briefs (Pittsburgh Post-Gazette)
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ATS Medical Announces US IDE Regulatory Submission for the ATS 3f Enable(TM) Aortic Bioprosthesis (PR Newswire via Yahoo! Finance)
ATS Medical, Inc. today reported that it has submitted its Investigational Device Exemption for the ATS 3f Enable Aortic Bioprosthesis to the FDA for review and approval.

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FDA Proposes New, Tougher Procedures for Membership on Advisory Committees
The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.

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FDA Proposes New, Tougher Procedures for Membership on Advisory Committees
The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.

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Schering-Plough to buy Akzo's Organon for $14.4 bln (Reuters via Yahoo! News)
Schering-Plough Corp has agreed to buy Akzo Nobel NV's drugs unit Organon BioSciences for 11 billion euros ($14.4 billion) in a bid to gain scale and diversify away from cholesterol medicine.

Organon unit to be acquired (The News & Observer)
'No cuts planned' for Organon facilities in Triangle, according to spokesman.

ICI Back in Takeover Spotlight As Akzo Builds EUR11bn War Chest (RedNova)
By Karen Attwood Shares in ICI, the UK'

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Wyeth Receives FDA Approval for New BeneFIX Features That Provide Hemophilia B Patients a Simpler and More Convenient ... (PR Newswire via Yahoo! Finance)
Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has received approval from the U.S. Food and Drug Administration for new product enhancements for BeneFIX Coagulation Factor IX that will offer patients a simpler and more convenient preparation process compared with the original BeneFIX preparation process.

FDA Warning Letter Web Site Convicts Companies Unfairly (Medical Device Link)
An old saying has it that justice must not only be done, but it must be seen to be done. By this standard, FDA s warning letters Web page would seem to fail miserably.

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ArteFill
ArteFill is a filler that is injected into the nasolabial folds around the mouth to smooth these wrinkles. The device contains small polymethylmethacrylate beads, collagen and lidocaine. (Approved: 10/27/2006)

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Ben and Jerry's Issues Allergy Alert on Undeclared Wheat in Ben and Jerry's Country Peach Cobbler Ice Cream
The following date codes: Jan 23, 2008; Jan 24, 2008; Feb 8, 2008; Feb 9, 2008 of Country Peach Cobbler are subject to the recall. The date code is found on the bottom of the pint.

Smith and Nephew Issues Nationwide Recall of RF Denervation Probes Used for the Spine
The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.

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Aethlon Medical Responds to U.S. Government Initiative to Develop and Acquire Broad-Spectrum Biodefense Countermeasures (Business Wire via Yahoo! Finance)
SAN DIEGO----Aethlon Medical, Inc. , announced today that the U.S. Government has disclosed plans to support research, development, acquisition, storage/maintenance, deployment, and utilization of broad-spectrum treatment countermeasures able to address multiple bioterror and pandemic threats.

Life Science Organizations Demand Standards-based Electronic Signatures for Document Management Systems (PRWeb via Yahoo! News)
Vienna, Austria (PRWeb) March 26, 2007 -- On the ten-year anniversary of the FDA issuance of the final rule for 21 CFR Part 11 for Electronic Records, standards-based electronic signatures (digital signatures) provider ARX (Algorithmic Research) substantiates life science organizations ever increasing requirement for Enterprise Content Management (ECM) vendors to support standards-based ...

Advancements in birth control give women more options (Burlington County Times)
Several FDA approvals during the past few months are providing more birth control options for women and offering protection against viruses that can cause cervical cancer and genital warts.

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Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
PDUFA provides user fee funds, paid by brand drug and biotechnology companies that are added to appropriated funds to support the review of new human drugs. Since 1992, when PDUFA was first enacted, FDA has provided the public with 1,220 new drugs and biologics. The current user fee program is scheduled to expire on September 30, 2007.

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Medistem Commences Pre-Clinical Research With Lawson Health Research Institute in London, Ontario in the Treatment of ... (Market Wire via Yahoo! Finance)
Medistem Laboratories, Inc. (Frankfurt: S2U) announced today that it is collaborating with Dr. Hao Wang, researcher at Lawson Health Research Institute and Assistant Professor, Department of Surgery at The University of Western Ontario in London, Ontario, to conduct pre-clinical research on Medistem's proprietary platform Tolerostem(TM). Subject to positive research results Medistem plans to ...

DOR BioPharma Announces FDA Clearance to Conduct Phase 2 Clinical Trial of orBec(R) for the Prevention of GVHD (RedNova)
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to conduct a Phase 2 clinical trial of orBec(R) for the prevention of Graft-versus-Host disease ("GVHD").

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