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Management: Food and Drug Administration (FDA)

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Total 5166 results found since Jan 2013.

This Week in Medicine January 25–31, 2014
The US Food and Drug Administration is recommending that health-care professionals discontinue prescribing and dispensing of prescription drugs containing more than 325 mg of paracetamol per dose. The recommendation is intended to reduce the risk of liver injury stemming from overdose or the combined intake of paracetemol products with alcohol.
Source: LANCET - January 24, 2014 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research

Regulating antibiotics in animals
HoThe Food and Drug Administration announced its plans to decrease the use of antibiotics in animals raised primarily for meat. According to the FDA, antibiotic-resistant bacteria are beginning to develop and have the potential to be transmitted from meat to humans.....
Source: Sound Medicine - February 2, 2014 Category: Global & Universal Authors: Sound Medicine Source Type: news

Anti-psychotic medications offer new hope in the battle against glioblastoma
(University of California - San Diego) Researchers at the University of California, San Diego School of Medicine have discovered that Food and Drug Administration-approved anti-psychotic drugs possess tumor-killing activity against the most aggressive form of primary brain cancer, glioblastoma.
Source: EurekAlert! - Medicine and Health - March 7, 2014 Category: Global & Universal Source Type: news

Patient safety merits new review for modified medical devices, physician says
(University of California - San Francisco) For patient safety, the US Food and Drug Administration should require that clinical data be submitted as part of a more rigorous re-evaluation of medical devices that are modified after approval. According to authors Rita Redberg, M.D., UCSF professor of medicine, and UCSF second-year medical student Sarah Zheng, such a requirement could prevent deaths due to insufficiently tested device modifications.
Source: EurekAlert! - Medicine and Health - March 25, 2014 Category: Global & Universal Source Type: news

Physical medicine devices; reclassification of stair-climbing wheelchairs. Final order.
Abstract The Food and Drug Administration (FDA) is issuing a final order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and further clarify the identification. PMID: 24741753 [PubMed - in process]
Source: Fed Regist - April 14, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Vemurafenib-induced bilateral facial palsy
FNU Shailesh, M Singh, U Tiwari, LF HutchinsJournal of Postgraduate Medicine 2014 60(2):187-188The United States Food and Drug Administration (FDA) approved Vemurafenib in August 2011, for treatment of melanoma with BRAF V600 mutation. It has shown improvement in the median overall survival of melanoma patients. The most common adverse effects of vermurafenib are arthralgia, rash, alopecia, photosensitivity and fatigue. Other infrequent and severe adverse reactions reported in patients include keratocanthomas, hypersensitivity, Stevens Johnson Syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and hepatotoxici...
Source: Journal of Postgraduate Medicine - May 13, 2014 Category: Internal Medicine Authors: FNU ShaileshM SinghU TiwariLF Hutchins Source Type: research

FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine
The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test – the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States.
Source: Food and Drug Administration - May 21, 2014 Category: American Health Source Type: news

FDA approves many drugs that predictably increase heart and stroke risk
(Case Western Reserve University) The agency charged to protect patients from dangerous drug side effects needs to be more vigilant when it comes to medications that affect blood pressure. Robert P. Blankfield, MD, MS, a clinical professor of family medicine, issues this call to the Food and Drug Administration in an editorial published recently in an online edition of the Journal of Cardiovascular Pharmacology and Therapeutics; the print version of the article is expected to appear this autumn.
Source: EurekAlert! - Medicine and Health - May 27, 2014 Category: Global & Universal Source Type: news

This Week in Medicine June 14–20, 2014
On June 2, the US Food and Drug Administration launched openFDA to improve access to important health datasets. Developed by the Office of Informatics and Technology Innovation, the initiative aims to make it easier to find information about reports of adverse events and recalls.
Source: LANCET - June 13, 2014 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research

Critical Drug Shortages: Implications for Emergency Medicine / Escasez Crítica de Medicamentos Fundamentales: Implicaciones para la Medicina de Urgencias y Emergencias
Abstract Prescription drug shortages have become increasingly common and more severe over the past decade. In addition, reported shortages are longer in duration and have had a greater effect on patient care. Some of the causes of current drug shortages are multifactorial, including the consolidation of drug manufacturers, quality problems at production plants that restrict the supply of drugs, and a lack of financial incentives for manufacturers to produce certain products, particularly generic medications. Generic injectable medications are most commonly affected by shortages because the production process is complex and...
Source: Academic Emergency Medicine - July 5, 2014 Category: Emergency Medicine Authors: Maryann Mazer‐Amirshahi, Ali Pourmand, Steven Singer, Jesse M. Pines, John Anker Tags: Special Contribution Source Type: research

Medical devices; physical medicine devices; classification of the nonpowered lower extremity pressure wrap. Final order.
Abstract The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 25016621 [PubMed - in process]
Source: Fed Regist - July 3, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Truly personalized medicine?
Abstract The patient wished to receive an experimental drug that she was instrumental in developing. After her diagnosis, she had investigated treatments that might help her condition and discovered that a specific compound could be beneficial. To further the development of this potential drug, she obtained preclinical data, founded a company, and sought investment from venture capitalists. The company was about to begin phase I testing, but the clinical trial had not yet opened. In addition, she would not have been a candidate for the study, as it excluded patients with advanced disease. To be able to administer ...
Source: The Hastings Center Report - July 1, 2014 Category: Medical Ethics Authors: Smith LB, Cooke CR, Goldman EB Tags: Hastings Cent Rep Source Type: research

Booming mobile health app market needs more FDA oversight for consumer safety, confidence
(Southern Methodist University) While the mobile health apps market offers tremendous potential, several health law experts say in a July 24 New England Journal of Medicine report that more oversight is needed by the US Food and Drug Administration to ensure consumer confidence and safety. Out of 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA, which opponents see as a deterrent to innovation and profit. But it doesn't have to be.
Source: EurekAlert! - Medicine and Health - July 28, 2014 Category: Global & Universal Source Type: news

Why regenerative stem cell medicine progresses slower than expected
Stem cell research has been acclaimed to revolutionize the future of medicine, and to offer new treatments for previously incurable diseases. Despite years of research, however, the therapeutic potential of stem cell research has not yet been fully realized. By June 2014 the US Food and Drug Administration had approved only five stem cell‐based medicinal products, all of which cord blood derived hematopoietic stem cell products for the cure of blood and immunological diseases. © 2014 Wiley Periodicals, Inc.
Source: Journal of Cellular Biochemistry - July 31, 2014 Category: Biochemistry Authors: Achim Rosemann Tags: View Points Source Type: research

Bedaquiline: A novel antitubercular drug for multidrug-resistant tuberculosis
H Nagabushan, HS RoopadeviJournal of Postgraduate Medicine 2014 60(3):300-302Multidrug-resistant and extensively drug-resistant tuberculosis (TB) are emerging global health threats. Bedaquiline is a new antituberculous drug belonging to the diarylquinoline class that efficiently inhibits the adenosine triphosphate synthase enzyme of Mycobacterium tuberculosis. It is a bactericidal and long-acting drug. It inhibits both dormant as well as replicating bacterial sub-populations and thus shortens the duration of TB treatment. This drug has been approved by the Food and Drug Administration in December 2012 for the management of...
Source: Journal of Postgraduate Medicine - August 14, 2014 Category: Internal Medicine Authors: H NagabushanHS Roopadevi Source Type: research