FDA Nanotechnology Task Force takes positive step forward
... The Task Force is clear and candid in acknowledging the pervasive potential of nanotechnology to affect virtually every product category FDA regulatesfrom pharmaceuticals and devices to cosmetics and food supplements and in calling for a wide range of FDA actions to prepare for and execute its oversight role. While available evidence does not suggest that...FDA sees nanotech challenges in every product category it regulates
WASHINGTON, DCAccording to Project on Emerging Nanotechnologies Director David Rejeski, Today, FDA took a step forward in fulfilling its responsibilities for nanotechnology oversight. If nanotechnology regulation was a baseball game, FDA has scored the first run in the first inning. But the agency must act rapidly to adopt and fully implement the Nanotechnology Task Forces recommendations. Witho...FDA finds no strong link between tomatoes and reduced cancer risk
... Several studies have reported an association between the consumption of tomatoes or lycopene, an antioxidant that gives tomatoes their red hue, and a decreased risk of some cancers, particularly prostate cancer. In order for foods and dietary supplements to be labeled with such health claims, the FDA must review a...Almac Diagnostics attends pre-IDE meeting with FDA
... Based on the meeting, Almac Diagnostics plans to accelerate the development and clearance of its In Vitro Diagnostic (IVD) utilizing the 510(k) approach to regulatory submiss...AACR, FDA and NCI announce cancer biomarkers collaborative at the AACR 2007 annual meeting
... ... "Major adva...Proposed FDA claim recognizes role of key nutrients in dairy in reducing osteoporosis risk
Rosemont, Ill. January 5, 2007 The Food and Drug Administration (FDA) has proposed an amended health claim that would communicate to consumers the value of foods high in calcium and vitamin D for reducing the risk of osteoporosis. The National Dairy Council (NDC) acknowledges and supports the body of scientific evidence that backs the proposed claim, which indicates that a lifestyle that incl...Cloning techniques produce FDA-approved antibiotic
The successful synthesis of an antibiotic in a non-native host has provided a team of researchers at the University of Illinois at Urbana-Champaign with the potential for developing new treatments for bacterial infections.... The rapid rise of antibiotic resistance poses a serious threat to human health, and demands new treatments effective against resistant pathogens. Fosfomycin is a natural an...AIUM supports FDA decision to deny over-the-counter use of handheld doppler fetoscopes
... The FDA conducted a public meeting on March 29, 2006, to discuss the issue in response to a petition for OTC use filed in June 2004. Representatives from the AIUM attended the session and provided both their input and opposition to the petition. AIUM President Lennard Greenbaum, MD, stated...FDA approves new epilepsy indication for Lamictal
... This new use marks the fifth FDA approval for Lamictal in epilepsy, making it one of the few antiepileptic drugs with esta...UK markey cancer center receives FDA approval to test novel cancer drug
Tom Burke died of colon cancer only a few years ago, but not before he helped create a new drug to fight cancer. That drug, currently called DB-67, recently received approval from the FDA for its use to be studied in cancer patients. The Markey Cancer Center at the University of Kentucky Chandler Hospital now has obtained Investigational New Drug status for DB-67 and will conduct the first clinic...First FDA clearance of sterile field cord blood collection bag
East Hills, NY and Cambridge, MA -- ViaCell, Inc. (NASDAQ: VIAC) and Pall Corporation (NYSE: PLL) announced today the first U.S. Food and Drug Administration clearance of a cord blood collection bag suitable for use in a sterile field. Pall and ViaCell collaborated on the development and design of the new collection bag. ViaCell has exclusive rights to the new collection bag for family cord blo...FDA grants Accentia Biopharmaceuticals...
Tampa, Fla. --Accentia Biopharmaceuticals, Inc. (Nasdaq:ABPI) has been notified that the U.S. Food and Drug Administration (FDA) granted Fast Track status to SinuNase , the Company's intranasal Amphotericin B formulation. To the best of the Company's knowledge, SinuNase is the first and only drug candidate for chronic sinusitis (CS) to receive Fast Track status from the FDA....... Under the FDA...FDA approves extended dosing of Aranesp
THOUSAND OAKS, Calif., (March 27, 2006) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved every-three-week dosing of Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia (low red blood cell count) in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating...Researchers reverse juvenile diabetes in animal model; Clinical trial FDA approved
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center researchers Massimo Trucco, MD, and Nick Giannoukakis, PhD, observed marked amelioration of diabetes in a mouse model by a novel treatment strategy involving specific modification of the animal's own dendritic cells, thereby reversing diabetes in animal studies. ......The U.S. Food and Drug Administration (FDA) approved...Scientists and clinicians from all over the country will attend the Food and Drug Administration's 2006 Science Forum from April 18-20, 2006. This unique conference brings together FDA scientists with their counterparts in industry, academia and government in an informal environment that promotes open discussion of emerging science and technology. ...... This year's Science Forum includes 23 ses...Biovest International submits amendment request to FDA for use of molecular remission data
Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) and its subsidiary, Biovest International, Inc. (OTCBB:BVTI), announces that it has made a formal amendment request to the FDA seeking to use pivotal Phase 3 data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission, to gain conditional approval of BiovaxID for treating follicular non-Hodgkin's...Biosense Webster receives FDA approval for technology to treat patients with heart rhythm disease
The U.S. Food and Drug Administration (FDA) today approved an innovative combination of technologies that will enhance a doctors' ability to treat patients with abnormal heart rhythms (cardiac arrhythmias). The approval results in the first and only commercially available products for use during cardiac radiofrequency ablation with the Niobe Magnetic Navigation System, designed by Stereotaxis, In...The Food and Drug Administration regulates consumer products that make up one-quarter of the U.S. economy. From its origins in the USDA Department of Chemistry, the FDA has grown to nearly 10,000 employees and has a $1.8 billion annual budget. Its role in overseeing our nation's food supply, cosmetics, human and veterinary drugs, and medical devices is a frequent topic of policy debate. ...... ....Society of Nuclear Medicine commends FDA for release of new guidance documents
The Society of Nuclear Medicine commends the Food and Drug Administration's Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs for their commitment to facilitating safe and effective research with today's release of two important documents regarding investigational new drugs. ... ... "Guidance for Industry and Reviewers:...FDA approves first medical device using Rutgers biomaterial
Rutgers scientists and TyRx Pharma, Inc., have announced the Food and Drug Administration's clearance of a new medical device for hernia repair that incorporates a biodegradable technology developed at the university. This action signals a paradigm shift in the application of biomaterials from permanent prosthetic replacements toward regenerative medicine, in which materials help the body to repa...First analysis of FDA's mifepristone adverse event reports
The abortion drug mifepristone (Mifeprex,TM RU-486), initially touted as a more convenient alternative to surgical abortion, has been linked to serious adverse reactions, including several deaths in otherwise healthy women. In "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," researchers Margaret M Gary MD and Donna J Harrison MD provide an in-depth study...FDA grants REVLIMID NDA approval
Celgene Corporation (NASDAQ: CELG) announced that the U.S. Food and Drug Administration (FDA) granted approval of REVLIMID (lenalidomide) which is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REV...FDA approves AVELOX (moxifloxacin HCl) for treatment of complicated intra-abdominal infections
Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily, broad-spectrum antibiotic AVELOX (moxifloxacin HCl) for a new use the treatment of complicated intra-abdominal infections (cIAI) in adults. AVELOX is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication. The FD...Pall tells FDA panel about blood filtering technology
East Hills, NY (Oct. 31, 2005) - - At the request of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathies (TSEs) Advisory Committee, Pall Corporation (NYSE: PLL) today presented the latest research results on its prion technology to remove TSE infectivity from blood. The Pall LeukotrapR Affinity Prion Reduction Filter system is the only Council of Europe (CE) marked t...North Shore-LIJ receives FDA approval for new drug application to manufacture PET scan drug
MANHASSET, NY -- The Institute for Medical Research of the North Shore-Long Island Jewish (LIJ) Health System today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture a drug used for diagnostic imaging with positron emission tomography (PET), a scanning technique that generates internal pictures of the human body at work. ...... The Institute's...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 (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original...GroPep announces US FDA approval of biopharmaceutical that uses its cell culture product
GroPep Limited (ASX: GRO) has today announced that a seventh biopharmaceutical product that uses the Company's Cell Culture Products in its manufacturing process, has obtained regulatory approval by the Food and Drug Administration (FDA) in the United States....... An application to market the product in the European Union has also been submitted, for which approval is expected in 2006....... Con...Student work in human subjects protection sought for FDA conference at UH
HOUSTON, March 23, 2005 From glucometers used by diabetics to stents used by cardiologists, new medical devices inevitably must be tested on human subjects. A national conference is seeking student work in the field of contemporary human subjects protection. ...... Co-sponsored by the Food and Drug Administration and the University of Houston, the April 21-22 event is one of only three annual...Pall prion removal technology presented to FDA blood products advisory committee
East Hills, NY (March 17, 2005) -- An update on Transmissible Spongiform Encephalopathies (TSEs), including variant Creutzfeldt-Jakob Disease (vCJD), the human form of "mad cow" disease, was a key topic at the Food & Drug Administration's Blood Products Advisory Committee meeting in Gaithersburg, Maryland today. Issues such as the number of people that could be harboring vCJD as carriers, the imp...Cardiologist to testify at FDA hearing: Animal tests implicated in Vioxx tragedy
WASHINGTON--On February 17, John J. Pippin, M.D., FA.C.C., will testify before Food and Drug Administration (FDA) officials and present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs. Dr. Pippin will represent the nonprofit Physicians Committee for Responsi...FDA approves ABRAXANE(TM) for metastatic breast cancer
SCHAUMBURG, IL January 7, 2005 American Pharmaceutical Partners, Inc. (NASDAQ:APPX) and American Bioscience, Inc. (ABI) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRAXANETM for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic breast cancer. ABRAXANE is indicated for the treatment of breast ca...Menssana research at NJIT receives kudos for FDA-approved breath test
In a fifth-floor laboratory at New Jersey Institute of Technology (NJIT), research assistant Renee Cataneo is holding the day's collection of human exhalations sent to Menssana Research, based at NJIT. Cataneo's job is to analyze the results. Just as a Breathalyzer detects drunk drivers, a Menssana process detects illness. ..."It's the same concept, but about a billion times more sensitive," sa...