FDA in Biological News

Hebrew University professor's work leads to FDA approval for product

Jerusalem, March 25, 2009 A material developed at the Hebrew University of Jerusalem that is designed to prevent adhesions (scar tissue) following surgery has led to approval by the U.S. Food and Drug Administration (FDA) of a product for use in pediatric cardiac surgery patients. The product...

Director of Berman Institute comments on FDA Approval of first human embryonic stem cell trial

"The report today that the FDA has approved the first human clinical trial of an embryonic stem cell-based intervention raises important ethical considerations, but not only, or even primarily, because what is at issue is an embryonic stem cell-based intervention. Although deep-seated disagreemen...

Expert urges FDA to take action to reduce BPA exposure

COLUMBIA, Mo. In the current issue of the Journal of the American Medical Association ( JAMA ), researchers report a significant relationship between urine concentrations of the environmental estrogen bisphenol A (BPA) and cardiovascular disease, type 2 diabetes and liver-enzyme abnormalities. ...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and...

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and...

UNC study questions FDA genetic-screening guidelines for cancer drug

CHAPEL HILL Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill. Irinotecan, also known by its bran...

American College of Medical Genetics responds to new FDA labeling decision for warfarin

BETHESDA, MD August 23, 2007 On August 16, the Food and Drug Administration approved new labeling information for the blood-thinner warfarin, sold under the brand name Coumadin. The new label suggests that one can prescribe higher or lower doses that may be safer for patients with variations in t...

Anthrax test, developed by army and CDC, receives FDA approval

A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (U...

More than half of Texas physicians do not always recommend HPV vaccine to girls

...y was published in Cancer Epidemiology, Biomarkers & Prevention , a journal of the American Association for Cancer Research. "Two years after the fda approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations," said Je...

Results from trials of DHA in Alzheimer's disease and age-related cognitive decline

...gnitive (ADAS-cog) and rate of change on Clinical Dementia Scale-sum of the boxes (CDR-SOB). These two measures are the current standard tests used by fda when assessing new Alzheimer's drugs. According to the researchers, treatment with DHA clearly increased blood levels of DHA, and also appeared to ...

New Report Just Published: World Solid-State, Fiber, Gas and Dye Lasers Market Report

... and BFi Launches Advanced 400 Watt DPSSL Platform II-48 IRIDEX Obtains fda Approval for IRIDEX IQ Laser Systems II-48 JDSU Unveils 4900 Series Pum... II-52 Fianium Launches New Fiber Laser Systems II-53 Solx Receives fda Approval for Glaucoma Treatment Laser II-53 ESI Unveils DPSS Laser for ...

Dietary supplements manufacturers gain new tool to help ensure quality products

...ry supplement and excipient standards for USP. "With the current cGMPs from fda stipulating that dietary supplements manufacturers determine the quality of... to compendial specifications (and such products being deemed misbranded by fda if they fail to so conform). USP has been setting quality standards for med...

Stanford researchers publish comprehensive model for medical device development

...hors, the model is used by the developers of both highly sophisticated premarket approval (PMA) and premarket notification (510(k)) devices, for which fda approval typically requires some risk-appropriate form of bench or clinical data, as well as by the makers of less sophisticated devices that may be e...

CWRU receives $5 million from Ohio Third Frontier Commission

...al reactions to cell related therapies for cancer. The goal of this project is to advance the commercialization of MultiStem cell therapy by running a fda approved Phase II clinical trial to evaluate the performance of the cells. Juventas Therapeutics, spin out company from Marc Penn (CC), will deve...

Trans fats hinder multiple steps in blood flow regulation pathways

...nated oils in it contains trans fat." "Partially hydrogenated fats can be made trans fat-free," Kummerow said. "The industry would be helped by an fda ban on trans fat that would save labeling costs, medical costs and lives." ...

Gene therapy could expand stem cells' promise

...s on even more urgency with recent developments, including a federal administration now more open to exploring the potential of stem cells, the recent fda approval of a human trial involving embryonic stem cells, as well as the reported case of a young boy who developed a brain tumor four years after rec...

NIH announces new program to develop therapeutics for rare and neglected diseases

...o test the therapy in patients. Clinical trials go through several stages that take several years to determine the safety and efficacy of a new drug. fda will only approve a drug for general use after it passes these trials. This is also an expensive process, but the failure rate is lower at this stage....

American Chemical Society's Weekly PressPac -- May 13, 2009

... with different concentrations of melamine. They found that these methods accurately detected the substance at levels as low as 1 ppm, meeting the new fda detection guidelines. The techniques take as little as 5 minutes to detect melamine and are relatively simple to use, requiring little or no sample pr...

GenWay Biotech obtains exclusive rights to AMDL's DR-70 cancer test in US and Canada

...agreements extend for five-years based on continuing success in both the Canadian and US markets. The DR-70 cancer test has been approved by the US fda for CRC monitoring and by Health Canada for Lung Cancer screening. However, a growing body of data reveals that the test is effective as a general ca...

Camphor-containing products may cause seizures in children

...Children are particularly vulnerable to the toxic effects of camphor, which is easily absorbed through the skin and mucous membranes. As a result, the fda limits the camphor content of common cold preparations, and federal and New York City regulations require that camphor-containing products be properly...

Treatment for extreme nausea, vomiting during pregnancy

... "In 2002, we had to quickly change the medication protocol to treat hyperemisis gravidarum (HG), or severe nausea and vomiting of pregnancy, due to a fda and Health Canada warnings," says senior researcher Anick Brard, a professor at the Universit de Montral's Faculty of Pharmacy and director of the Res...

Nutrition experts propose new class of low-sugar drinks to help stem obesity and diabetes epidemics

...Schools and workplaces: Offer several healthy beverage choices and smaller serving sizes. Also make sure water is freely available. Government: The fda should require companies to list the number of calories per bottle or cannot per servingon the front of beverage containers. ...

New drug shows promise in treating drug-resistant prostate cancer

... The promising laboratory studies led Medivation to license the drugs for commercial development. Medivation has received permission from the fda for a large Phase 3 clinical trial of MDV3100 on about 1,200 patients with anti-androgen-resistant disease. This study will assess MDV3100's effect on...

New therapeutic strategy could target toxic protein in most patients with Huntington's disease

... we had, which was that the number of siRNAs we would have to test in order to have impact on the disease would be too large, and as a consequence the fda would never approve any trial," he continued. By adding an siRNA against one of two other common SNPs, Zamore says gene silencing could be effectiv...

Ambati study published in PNAS

...demy of Sciences. In the earlier study, the Ambati laboratory discovered previously unrecognized immune side effects of siRNA, which is currently in fda trials for numerous diseases including age-related macular degeneration and life-threatening viral infections. Specifically, they showed that in t...

CEL-SCI Corporation to Launch Aseptic Filling for Stem Cell Produced Therapies and Other Biological Products

...s, including humidity control. The Aseptic filling suites are maintained at fda and EU ISO classifications of 5/6. CEL-SCI also has additional capability ...drugs, biologics and stem cell therapies. It is an absolute requirement by fda and any other regulatory agency that a drug developer must demonstrate the ...

SNM Symposium on Multimodality Cardiovascular Molecular Imaging

...l metabolism and myocardial repair. SNM and the International Partnership for Critical Markers of Disease will host a satellite meeting devoted to fda requirements for manufacturing PET radiopharmaceuticals the evening of Friday, May 1. This meeting will take place immediately following the conclusio...

The American Association for Cancer Research congratulates Margaret Hamburg, M.D.

...lead the Food and Drug Administration (FDA). As fda commissioner, Hamburg will oversee the advancement...eadership will bring new perspectives to important fda initiatives, such as devising regulatory pathways ...iative, make her an ideal candidate to provide the fda with a fresh vision for the future. As the auth...

Waking up dormant HIV

...uld activate latent HIV, but the risk of several toxic side effects made HMBA clinically non-viable. However, the chemically similar SAHA had received fda approval, making it a potentially safer alternate. So, the researchers examined whether SAHA had any effect on HIV latency. They found that SAHA co...

Chantix side effects no worse with depression history

...ly monitoring patients on this drug." Varenicline is the latest drug the fda has approved to help tobacco users quit. It seems more effective than other...y in people with a history of psychiatric problems. This has led to several fda advisories. COMPASS confirmed previous findings that varenicline side ef...

Parkinson's Disease Foundation awards $300,000 in bridge funding for innovative research projects

...hat may shed light on new ways of treating Parkinson's. Dr. Greenamyre, for example, will test several classes of medications already approved by the fda for diseases other than Parkinson's to observe whether they are effective in improving gastrointestinal motility in Parkinson's. Despite the frequenc...

Veterinarians developing model to help producers, vets make cattle more comfortable

...a $325,000 grant from the U.S. Department of Agriculture to develop a model to assess pain in cattle. Coetzee said ultimately this model will help the fda evaluate drugs for cattle by knowing how well they work and to recommend proper dosing. "Managing pain is an inherently good idea, but it is critic...

Food counterfeiting, contamination outpace international regulatory systems

...a valuable perspective by understanding source country economies and cultures, Spink said. Also participating in the forum were presenters from the fda and Cargill Inc., representing regulatory and corporate perspectives. ...

Acorda Therapeutics submits new drug application for Fampridine-SR in multiple sclerosis

...ultiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the fda to complete its review within ten months from receipt of the submission. "This NDA filing is a major milestone for Acorda and our Fampridine-SR de...

New asthma research opposes current drug treatment, says UH prof

...ly release of this study comes on the heels of the fda considering a renewed look at the use of long-acti...ent for the management of asthma symptoms. In an fda report released in December, an analysis of more t... the LABA-only therapy. During the same month, an fda advisory panel urged the...

42nd Mid-year Topical Meeting of the Health Physics Society

... Identifying enriched uranium Federal Agency planning (Tuesday a.m. session) EPA update of the protective action guides (PAGs) DHS/FEMA planning fda protective action recommendations ...

Musculoskeletal center wins $2.2 million for drug safety

..." The CERTs study will boost understanding of the risks and benefits of these drugs and better guide medical professionals, drug manufacturers, the fda and the Agency for Healthcare and Quality (AHRQ), an agency within the Department Health and Human Services. AHRQ awarded the $2.2 million to UAB. ...

First at-home test for vasectomized men proves to be safe, accurate

... Virginia Health System researcher John C. Herr, PhD and his colleagues have confirmed the accuracy and reliability of SpermCheck Vasectomy, the first fda approved at-home immunodiagnostic test for detecting low concentrations of sperm. Herr, a professor of Cell Biology and director of UVA's Center f...

MSU researcher studies ties between cholesterol drugs, muscle problems

...l off the market after it appeared to be responsible for 31 deaths through a potentially fatal breakdown of muscle tissue known as rhabdomyolysis. The fda at the time said the muscle breakdown occurred more frequently in patients taking Baycol than in patients on other statins. The National Lipid Associa...

Medicare coding for maggots and maggot therapy

...e use of specially prepared fly larvae for treating chronic wounds. Medical Maggots brand of medicinal maggots were granted marketing clearance by the fda in 2004 for treating neuropathic (i.e., diabetic) foot ulcers, pressure ulcers ("bed sores"), venous stasis ulcers, and traumatic and post-surgical wo...