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Clinical Trial News |
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| FDA approves Ferriprox to treat patients with excess iron in the body
2011-10-19 00:00:00.0
The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm.
The standard of care to treat transfusional iron overload is chelation therapy - chemical agents that are used to remove heavy metals from the body. Ferriprox is intended for ( read more)..... |
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| FDA, CMS launch pilot program for voluntary parallel review of innovative devices Aim is to reduce time between FDA approval and CMS national coverage determinations
2011-10-07 00:00:00.0
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a "parallel review" pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.
The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.
"The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effe( read more)..... |
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| FDA approves Cialis to treat benign prostatic hyperplasia
2011-10-06 00:00:00.0
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.
Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.
The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significa( read more)..... |
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| FDA and NIH announce joint study on tobacco use and risk perceptions Landmark collaboration is the first since the passing of the 2009 Tobacco Control Act
2011-10-06 00:00:00.0
The U.S. Food and Drug Administration and the National Institutes of Health today announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations.
The initiative, called the Tobacco Control Act National Longitudinal Study of Tobacco Users, is the first large-scale NIH/FDA collaboration on tobacco regulatory research since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009.
Scientific experts at NIH's National Institute on Drug Abuse and the FDA's Center for Tobacco Products will coordinate the effort.
"The launch of this study signals a major milestone in addres( read more)..... |
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| FDA works to improve science used to approve medical devices
2011-10-03 00:00:00.0
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products.
The report, "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health," offers a look at the work FDA engages in every day to help foster science that enables and supports innovation and sound medical product development.
"The regulatory science plan provides an informative and transparent look at the work we conduct in collaboration with industry and academia to facilitate the develo( read more)..... |
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| US Food and Drug Administration US FDA announces changes in drug center's oncology office Review divisions to be aligned by expertise, disease-specific areas
2011-09-12 00:00:00.0
Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research's (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).
"Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market," said CDER director Janet Woodcock, M.D. "We don't expect these changes to slow down pending applications, in fact, we expect to see greater efficiencies that will better support our work to get cancer treatment( read more)..... |
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| US Food and Drug Adminsitration FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer Second targeted therapy approved with a test this year
2011-08-26 00:00:00.0
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.
This ALK gene abnormality causes cancer development and growth. About 1 percent to 7 percent of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers. Xalkori wo( read more)..... |
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| US Food and Drug Administration US FDA approves Firazyr to treat acute attacks of hereditary angioedema
2011-08-25 00:00:00.0
The U.S. Food and Drug Administration US FDA today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE.
People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nau( read more)..... |
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| US Food and Drug Administration US FDA approves Botox to treat specific form of urinary incontinence
2011-08-25 00:00:00.0
The U.S. Food and Drug Administration US FDA today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.
The treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity and a decrease in urinary incontinence.
"Urinary incontinence associated with neurologi( read more)..... |
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