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Food and Drug Administration Approval for Use of Hiberix as a 3-Dose Primary Haemophilus influenzae Type b (Hib) Vaccination Series.
Abstract On January 14, 2016, GlaxoSmithKline Biologicals (Research Triangle Park, North Carolina) received approval from the Food and Drug Administration (FDA) to expand use of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) for a 3-dose infant primary vaccination series at ages 2, 4, and 6 months. Hiberix was first licensed in the United States in August 2009 for use as a booster dose in children aged 15 months through 4 years under the Accelerated Approval Regulations, in response to a Haemophilus influenzae type b (Hib) vaccine shortage that lasted from December 2007 to July 2009 (1). Expan...
Source: MMWR Morb Mortal Wkl... - April 30, 2016 Category: Epidemiology Authors: Briere EC Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Identification of "Multiple Components-Multiple Targets-Multiple Pathways" Associated with Naoxintong Capsule in the Treatment of Heart Diseases Using UPLC/Q-TOF-MS and Network Pharmacology.
Authors: Ma X, Lv B, Li P, Jiang X, Zhou Q, Wang X, Gao X Abstract Naoxintong capsule (NXT) is a commercial medicinal product approved by the China Food and Drug Administration which is used in the treatment of stroke and coronary heart disease. However, the research on the composition and mechanism of NXT is still lacking. Our research aimed to identify the absorbable components, potential targets, and associated pathways of NXT with network pharmacology method. We explored the chemical compositions of NXT based on UPLC/Q-TOF-MS. Then, we used the five principles of drug absorption to identify absorbable ingredien...
Source: Evidence-based Complementary and Alternative Medicine - April 29, 2016 Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research

Update on monitoring and adverse effects of first generation disease modifying therapies and their recently approved versions in relapsing forms of multiple sclerosis
Purpose of review: As of April 2015, 13 disease modifying therapies (DMTs) have been approved by the Food and Drug Administration. The older agents continue to be utilized across the globe, especially in developing countries where many newer DMTs are still not available. Even though first generation DMTs have modest efficacy they have long term safety profile, and are considered safer than the second generation DMTs. Recent findings: A PEGylated interferon beta-1a preparation that is administered subcutaneously every 2 weeks was also recently approved. Less frequent administration potentially reduced administration associ...
Source: Current Opinion in Neurology - April 29, 2016 Category: Neurology Tags: DEMYELINATING DISEASES: Edited by Hans-Peter Hartung Source Type: research

Therapeutic advances for primary biliary cholangitis: the old and the new
This article reviews the therapeutic advances of these old and new medications in patients with PBC. (Source: European Journal of Gastroenterology and Hepatology)
Source: European Journal of Gastroenterology and Hepatology - April 29, 2016 Category: Gastroenterology Tags: Review Articles Source Type: research

Molecules, Vol. 21, Pages 529: Nerolidol: A Sesquiterpene Alcohol with Multi-Faceted Pharmacological and Biological Activities
Nerolidol (3,7,11-trimethyl-1,6,10-dodecatrien-3-ol) is a naturally occurring sesquiterpene alcohol that is present in various plants with a floral odor. It is synthesized as an intermediate in the production of (3E)-4,8-dimethy-1,3,7-nonatriene (DMNT), a herbivore-induced volatile that protects plants from herbivore damage. Chemically, nerolidol exists in two geometric isomers, a trans and a cis form. The usage of nerolidol is widespread across different industries. It has been widely used in cosmetics (e.g., shampoos and perfumes) and in non-cosmetic products (e.g., detergents and cleansers). In fact, U.S. Food and Drug ...
Source: Molecules - April 28, 2016 Category: Chemistry Authors: Weng-Keong ChanLoh TanKok-Gan ChanLearn-Han LeeBey-Hing Goh Tags: Review Source Type: research

The Basis of Structure/Function Claims of Nutraceuticals
Abstract In the United States, as in most of the world, there are large numbers of nutraceuticals that are sold and which people take to boost their immune response. There are, in addition, almost an equal number of products sold to reduce allergies. However, very few consumers, and indeed physicians, are aware of what a structure/function claim is. Structure/function claims are labeling claims that can be used to describe the potential effects of a dietary ingredient or similar substance on the structure or function of the human body. This category of claims was created by legislation contained in the Dietary Sup...
Source: Clinical Reviews in Allergy and Immunology - April 28, 2016 Category: Allergy & Immunology Source Type: research

An expanded pharmacogenomics warfarin dosing table with utility in generalised dosing guidance.
Abstract Pharmacogenomics (PGx) guided warfarin dosing, using a comprehensive dosing algorithm, is expected to improve dose optimisation and lower the risk of adverse drug reactions. As a complementary tool, a simple genotype-dosing table, such as in the US Food and Drug Administration (FDA) Coumadin drug label, may be utilised for general risk assessment of likely over- or under-anticoagulation on a standard dose of warfarin. This tool may be used as part of the clinical decision support for the interpretation of genetic data, serving as a first step in the anticoagulation therapy decision making process. Here we ...
Source: Thrombosis and Haemostasis - April 28, 2016 Category: Hematology Authors: Shahabi P, Scheinfeldt LB, Lynch DE, Schmidlen TJ, Perreault S, Keller MA, Kasper R, Wawak L, Jarvis JP, Gerry NP, Gordon ES, Christman MF, Dubé MP, Gharani N Tags: Thromb Haemost Source Type: research

FDA okays glycopyrrolate/formoterol combo for COPD
The Food and Drug Administration has approved glycopyrrolate and formoterol fumarate inhalation aerosol for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive... (Source: Internal Medicine News)
Source: Internal Medicine News - April 27, 2016 Category: Internal Medicine Source Type: research

FDA evaluating the use of oral fluconazole in pregnancy
The Food and Drug Administration is reviewing the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) in pregnancy,... (Source: Ob.Gyn. News)
Source: Ob.Gyn. News - April 26, 2016 Category: OBGYN Source Type: research

After Inflectra’s approval, challenges remain for biosimilars
Now that the Food and Drug Administration has approved Inflectra as the first biosimilar version of the anti–tumor necrosis factor-alpha agent Remicade, rheumatologists and patient advocacy groups... (Source: Rheumatology News)
Source: Rheumatology News - April 26, 2016 Category: Rheumatology Source Type: research

PLGA based drug delivery systems: Promising carriers for wound healing activity
Abstract Wound treatment remains one of the most prevalent and economically burdensome healthcare issues in the world. Current treatment options are limited and require repeated administrations which led to the development of new therapeutics to satisfy the unmet clinical needs. Many potent wound healing agents were discovered but most of them are fragile and/or sensitive to in vivo conditions. Poly(lactic‐co‐glycolic acid) (PLGA) is a widely used biodegradable polymer approved by food and drug administration and European medicines agency as an excipient for parenteral administrations. It is a well‐established drug d...
Source: Wound Repair and Regeneration - April 26, 2016 Category: Surgery Authors: Kiran Kumar Chereddy, Gaëlle Vandermeulen, Véronique Préat Tags: Perspective Article Source Type: research

Meta-analysis of dipeptidyl peptidase-4 inhibitors use and cardiovascular risk in patients with type 2 diabetes mellitus
Diabetes is known as one of the risk factors for the incidence of cardiovascular events [1,2]. In addition to the condition itself, it has been reported that some drugs used for the treatment of diabetes such as rosiglitazone increase the risk of cardiovascular events [3]. There are growing concerns about the association between the use of hypoglycemic drugs and cardiovascular events, and therefore the US Food and Drug Administration (FDA) requires pharmaceutical companies to evaluate this association through clinical trials [4]. (Source: Diabetes Research and Clinical Practice)
Source: Diabetes Research and Clinical Practice - April 26, 2016 Category: Endocrinology Authors: Masayuki Kaneko, Mamoru Narukawa Source Type: research

FDA allows metformin for patients with mild to moderate kidney impairment
The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin‐containing medicines for diabetes to expand metformin's use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. The FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can r...
Source: The Brown University Child and Adolescent Psychopharmacology Update - April 25, 2016 Category: Psychiatry Tags: From the FDA Source Type: research

Inter-observer Variability Analysis of Automatic Lung Delineation in Normal and Disease Patients
This study focuses on the variability from different observers that interact with an automated lung delineation system that relies on human interaction in the form of delineation of the lung borders. The database consists of High Resolution Computed Tomography (HRCT): 15 normal and 81 diseased patients’ images taken retrospectively at five levels per patient. Three observers manually delineated the lungs borders independently and using software called ImgTracer™ (AtheroPoint™, Roseville, CA, USA) to delineate the lung boundaries in all five levels of 3-D lung volume. The three observers consisted of Observer-1: lesse...
Source: Journal of Medical Systems - April 25, 2016 Category: Information Technology Source Type: research

U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?
PMID: 27101113 [PubMed - in process] (Source: Obstetrics and Gynecology)
Source: Obstetrics and Gynecology - April 23, 2016 Category: OBGYN Authors: Baggish M Tags: Obstet Gynecol Source Type: research

Electromagnetic Navigational Bronchoscopy for Peripheral Pulmonary Nodules
Electromagnetic navigational bronchoscopy is a useful addition to the array of modalities available to sample peripheral lung lesions. Its utility in diagnosing peripheral lesions has been steadily increasing since the Food and Drug Administration first approved it in 2004. The improvement can be attributed to continuous refinement in technology, increasing training and experience with the procedure, perhaps widespread availability of rapid onsite cytologic evaluation, and better patient selection. It may also be attributable to improvements of the technology and more available tools to perform biopsy of the peripheral lun...
Source: Thoracic Surgery Clinics - April 23, 2016 Category: Cardiovascular & Thoracic Surgery Authors: Satish Kalanjeri, Thomas R. Gildea Source Type: research

The Cardiac Safety Research Consortium Enters its Second Decade: An Invitation to Participate
Publication date: Available online 23 April 2016 Source:American Heart Journal Author(s): J. Rick Turner, Peter R. Kowey, Ignacio Rodriguez, Christopher H. Cabell, Gary Gintant, Cynthia L. Green, Barbara Lopez Kunz, Justin Mortara, Philip T. Sager, Norman Stockbridge, Theressa J. Wright, John Finkle, Mitchell W. Krucoff The Cardiac Safety Research Consortium (CSRC), a transparent, public-private partnership established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University, is entering its second...
Source: American Heart Journal - April 23, 2016 Category: Cardiology Source Type: research

The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting
The combination of netupitant and palonosetron was approved by the Food and Drug Administration in October 2014 for the prevention of acute and delayed chemotherapy-induced nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic chemotherapy. Netupitant and palonosetron is available as a single capsule to be administered prior to each cycle of chemotherapy. The approval was based on phase II and III data in patients undergoing treatment with moderately and highly emetogenic chemotherapy. Netupitant and palonosetron’s benefits include a convenient dosage form, dual-targeted m...
Source: Journal of Oncology Pharmacy Practice - April 22, 2016 Category: Cancer & Oncology Authors: Abramovitz, R. B., Gaertner, K. M. Tags: Review Articles Source Type: research

Glycopeptide Antibiotics Inhibit Virus Entry [Microbiology]
In this study, via high throughput screening of Food and Drug Administration-approved drugs, we identified that teicoplanin, a glycopeptide antibiotic, potently prevents the entry of Ebola envelope pseudotyped viruses into the cytoplasm. Furthermore, teicoplanin also has an inhibitory effect on transcription- and replication-competent virus-like particles, with an IC50 as low as 330 nm. Comparative analysis further demonstrated that teicoplanin is able to block the entry of Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) envelope pseudotyped viruses as well. Teicoplanin derivatives such...
Source: Journal of Biological Chemistry - April 22, 2016 Category: Chemistry Authors: Zhou, N., Pan, T., Zhang, J., Li, Q., Zhang, X., Bai, C., Huang, F., Peng, T., , Liu, C., Tao, L., Zhang, H. Tags: Microbiology Source Type: research

Validation of TURN, a simple Predictor of Symptomatic Intracerebral Hemorrhage after IV Thrombolysis
Intravenous thrombolysis (rt-PA) remains the only medical treatment for acute ischemic stroke approved by the Food and Drug Administration (FDA), but carries a substantial risk for symptomatic intracerebral hemorrhage (sICH) [1]. Predictive scores for sICH may help improve the safety profile for rt-PA treatment. (Source: Clinical Neurology and Neurosurgery)
Source: Clinical Neurology and Neurosurgery - April 22, 2016 Category: Neurosurgery Authors: David Asuzu, Karin Nystrӧm, Hardik Amin, Joseph Schindler, Charles Wira, David Greer, Nai Fang Chi, Janet Halliday, Kevin N. Sheth Source Type: research

The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia: A Case Series of 5 Cesarean Deliveries Complicated by Paresthesias and Headaches
We present a case series of 5 cesarean deliveries using the Wiley Spinal intrathecal system (Epimed, Johnstown, New York), which was recently approved by the US Food and Drug Administration. The intrathecal catheter system consists of a flexible 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle. The placement of the intrathecal catheter was successful in all 5 cases; however, paresthesias in 3 cases and postdural puncture headaches in 2 cases complicated the placement and use of the device. Although the unique catheter-over-needle design facilitates the use of smaller-gauge spinal needles for dural pu...
Source: Regional Anesthesia and Pain Medicine - April 21, 2016 Category: Anesthesiology Tags: Obstetric Analgesia: Case Report Source Type: research

The role of Akt (protein kinase B) and protein kinase C in ischemia-reperfusion injury.
Authors: Zhao EY, Efendizade A, Cai L, Ding Y Abstract Stroke is a leading cause of long-term disability and death in the United States. Currently, tissue plasminogen activator (tPA), is the only Food and Drug Administration-approved treatment for acute ischemic stroke. However, the use of tPA is restricted to a small subset of acute stroke patients due to its limited 3-h therapeutic time window. Given the limited therapeutic options at present and the multi-factorial progression of ischemic stroke, emphasis has been placed on the discovery and use of combination therapies aimed at various molecular targets contrib...
Source: Neurological Research - April 21, 2016 Category: Neurology Tags: Neurol Res Source Type: research

FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude tha...
Source: Tobacco Control - April 21, 2016 Category: Respiratory Medicine Authors: Jenson, D., Lester, J., Berman, M. L. Tags: Editor's choice Special communication Source Type: research

Tobacco documents reveal questionable professional recertification by industry menthol expert
Jonathan Daniel Heck, PhD, a board certified toxicologist, career scientist at Lorillard Tobacco, and industry expert on menthol, served as an industry representative on the Food and Drug Administration (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) from 2010 through 2014. In 2011, Heck was the lead author of the "Industry Menthol Report; Menthol Cigarettes: No Disproportionate Impact on Public Health"1 submitted to the FDA. To become certified and maintain his status as a board certified toxicologist, Heck took a certification examination and multiple recertification examinations administered by the American...
Source: Tobacco Control - April 21, 2016 Category: Respiratory Medicine Authors: Stevens, D., Glantz, S. Tags: Industry watch Source Type: research

Improving the Quality of Compounded Sterile Drug Products: A Historical Perspective
This article describes the history of the practice and regulation of pharmacy compounding, culminating in the passage by Congress of the Compounding Quality Act of 2014. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 21, 2016 Category: Drugs & Pharmacology Authors: Cantrell, S. A. Tags: Special Section on Pharmaceutical Compounding Source Type: research

Evaluating the Cardiovascular Safety of New Medications for Type 2 Diabetes: Time to Reassess?
The U.S. Food and Drug Administration (FDA) issued a Guidance for Industry in 2008 defining preapproval and postapproval requirements for the demonstration of cardiovascular safety for all new medications developed for glycemic management in type 2 diabetes. Seventeen large, prospective, randomized, controlled clinical trials involving more than 140,000 subjects thus far have been completed or are ongoing in accordance with this guidance. All five of the completed trials, involving three different drug classes, have met their primary objective to exclude an unacceptable level of ischemic cardiovascular risk as defined in t...
Source: Diabetes Care - April 21, 2016 Category: Endocrinology Authors: Smith, R. J.; Goldfine, A. B.; Hiatt, W. R. Tags: Cardiovascular Disease and Diabetes Source Type: research

Correction of Misleading Information in Prescription Drug Television Advertising: The Roles of Advertisement Similarity and Time Delay
Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. (Source: Research in Social and Administrative Pharmacy)
Source: Research in Social and Administrative Pharmacy - April 21, 2016 Category: Pharmaceuticals Authors: Kathryn J. Aikin, Brian G. Southwell, Ryan S. Paquin, Douglas J. Rupert, Amie C. O’Donoghue, Kevin R. Betts, Philip K. Lee Source Type: research

251 Identification of alpha-adrenergic agonists as potential therapeutic agents for dermatomyositis through drug-repurposing using public expression datasets
Dermatomyositis (DM) is a systemic autoimmune disorder characterized by inflammation of the skin and muscle. Current therapeutics for the skin lesions in DM is limited, reinforcing the need for a systematic approach to discover novel therapeutics. Here, we applied a bioinformatics approach combining gene expression data from 38 lesional DM skin biopsies with gene expression data from over 1,600 U.S. Food and Drug Administration (FDA)-approved small molecules to identify potential novel therapeutics for DM. (Source: Journal of Investigative Dermatology)
Source: Journal of Investigative Dermatology - April 20, 2016 Category: Dermatology Authors: H.G. Cho, D. Fiorentino, M. Lewis, M. Sirota, K. Sarin Tags: Clinical Research II: Pathophysiology and Therapeutics Source Type: research

E-Cigarette Warning Labels to Prevent Adolescent Use: A Letter Response
We thank the authors Braillon and Nolte for suggesting a role for warning labels on disposable electronic nicotine delivery systems (ENDSs) and nicotine refill cartridges [1]. In April 2014, in a move that asserts jurisdiction over ENDS, the Food and Drug Administration-Center for Tobacco Products (FDA-CTP) proposed the following warning label for disposable ENDS, cartridges, and liquid nicotine: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical” (Figure 1) [2]. (Source: Journal of Adolescent Health)
Source: Journal of Adolescent Health - April 20, 2016 Category: Child Development Authors: Jenna M. Hughes, Gordon J. Hildick-Smith, Michael F. Pesko, Lee Shearer, Jane Chang, Gerald M. Loughlin, Lisa S. Ipp Tags: Letter to the editor Source Type: research

Imaging the Posterior Pole in Glaucoma: Necessary But Not Sufficient
The role of imaging in the diagnosis of glaucoma is unclear but of great clinical importance. The volume of glaucoma-related imaging performed has been increasing steadily despite a lack of firm evidence to support its usefulness.1 Regional differences in the volume of imaging in the United States suggest that there is no consensus about the indications for imaging.2 The United States Food and Drug Administration and the American Glaucoma Society have discussed pertinent issues at a recent workshop. (Source: Ophthalmology)
Source: Ophthalmology - April 20, 2016 Category: Opthalmology Authors: Tianjing Li, Henry D. Jampel Tags: Editorial Source Type: research

Expert consensus on the rational clinical use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
Authors: Achimastos A, Alexandrides T, Alexopoulos D, Athyros V, Bargiota A, Bilianou E, Chrysochoou C, Drogari E, Elisaf M, Ganotakis E, Goudevenos I, Ioannidis I, Kolovou G, Kotsis V, Lekakis I, Liberopoulos E, Melidonis A, Nikolaou V, Ntaios G, Papanas N, Pappas S, Pitsavos C, Rallidis L, Richter D, Skoumas I, Tentolouris N, Tousoulis D, Tselepis A, Tsioufis K, Tziakas D, Tziomalos K, Vardas P, Vlachopoulos C, Vlahakos D Abstract Two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, evolocumab and alirocumab, have recently been approved by both the Food and Drug Administration (FDA) and the Europ...
Source: Hormones - April 19, 2016 Category: Endocrinology Tags: Hormones (Athens) Source Type: research

Priority Review Voucher Program
To the Editor Dr Kesselheim and colleagues assessed the priority review voucher program, which rewards companies for US Food and Drug Administration (FDA) registration of treatments for rare pediatric or neglected diseases. We have a more optimistic view of the program. (Source: JAMA)
Source: JAMA - April 19, 2016 Category: Journals (General) Source Type: research

Devices and techniques for ERCP in the surgically altered GI tract
The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - April 19, 2016 Category: Gastroenterology Authors: ASGE Technology Committee, Brintha K. Enestvedt, Shivangi Kothari, Rahul Pannala, Julie Yang, Larissa L. Fujii-Lau, Joo Ha Hwang, Vani Konda, Michael Manfredi, John T. Maple, Faris M. Murad, Karen L. Woods, Subhas Banerjee Tags: Technology status evaluation report Source Type: research

2015 in review: FDA approval of new drugs.
Abstract The myriad new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2015 reflected both the opportunities and risks associated with the development of new medicines. On the one hand, the approval of 45 NMEs was among the highest ever recorded. Likewise, the diversity underlying the mechanistic basis of new medicines suggests continued broadening relative to the predominate trends of the past few decades. On the other hand, closer inspection indicates that business model decisions surrounding orphan indications and consolidation could be placing the industry in an ever-more pre...
Source: Drug Discovery Today - April 19, 2016 Category: Drugs & Pharmacology Authors: Kinch MS Tags: Drug Discov Today Source Type: research

Cyclin‐Dependent Kinase Inhibitors for the Treatment of Breast Cancer: Past, Present, and Future
This article is protected by copyright. All rights reserved. (Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy)
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - April 18, 2016 Category: Drugs & Pharmacology Authors: Adam J. DiPippo, Neelam K. Patel, Chad M. Barnett Tags: Review of Therapeutics Source Type: research

A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing
Abstract Bench‐top in vitro hemolysis testing is a fundamental tool during the design and regulatory safety evaluation of blood‐contacting medical devices. While multiple published experimental protocols exist, descriptions of the test loop reservoir remain ambiguous. A critical fixture within the circuit, there is no readily available blood reservoir that ensures thorough mixing and complete air evacuation: two major factors which can affect results. As part of the Food and Drug Administration (FDA) Critical Path Initiative, we developed a three‐piece reservoir consisting of a 3D‐printed base, a plastic clamp set,...
Source: Artificial Organs - April 18, 2016 Category: Transplant Surgery Authors: Salim E. Olia, Luke H. Herbertson, Richard A. Malinauskas, Marina V. Kameneva Tags: Thoughts and Progress Source Type: research

Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers. Final order.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers. Final order. Fed Regist. 2016 Apr 18;81(74):22525-30 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject t...
Source: Fed Regist - April 18, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

ENDOCANNABINOID SYSTEM: A multi-facet therapeutic target.
Abstract Cannabis sativa is also popularly known as marijuana. It is being cultivated and used by man for recreational and medicinal purposes from many centuries. Study of cannabinoids was at bay for very long time and its therapeutic value could not be adequately harnessed due to its legal status as proscribed drug in most of the countries. The research of drugs acting on endocannabinoid system has seen many ups and down in recent past. Presently, it is known that endocannabinoids has role in pathology of many disorders and they also serve "protective role" in many medical conditions Several diseases like emesis, ...
Source: Current Clinical Pharmacology - April 17, 2016 Category: Drugs & Pharmacology Authors: Kaur R, Ambwani SR, Singh S Tags: Curr Clin Pharmacol Source Type: research

Survey of Blood Collection Centers and Implementation of Guidance for Prevention of Transfusion-Transmitted Zika Virus Infection - Puerto Rico, 2016.
Abstract Since November 2015, Puerto Rico has reported active mosquito-borne transmission of Zika virus (1). Because of the potential for Zika virus to be transmitted through transfusion of blood components, and because a high percentage of persons infected with Zika virus are asymptomatic (2), the Food and Drug Administration (FDA) recommended that blood collections cease in areas of the United States affected by active vector-borne transmission of Zika virus until laboratory screening of blood donations or pathogen reduction technology (PRT)* for treatment of blood components can be implemented (3). To inform eff...
Source: MMWR Morb Mortal Wkl... - April 16, 2016 Category: Epidemiology Authors: Vasquez AM, Sapiano MR, Basavaraju SV, Kuehnert MJ, Rivera-Garcia B Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Tobacco Use Among Middle and High School Students - United States, 2011-2015.
Abstract Tobacco use is the leading cause of preventable disease and death in the United States; if current smoking rates continue, 5.6 million Americans aged <18 years who are alive today are projected to die prematurely from smoking-related disease (1). Tobacco use and addiction mostly begin during youth and young adulthood (1,2). CDC and the Food and Drug Administration (FDA) analyzed data from the 2011-2015 National Youth Tobacco Surveys (NYTS) to determine the prevalence and trends of current (past 30-day) use of seven tobacco product types (cigarettes, cigars, smokeless tobacco, electronic cigarettes [e-ci...
Source: MMWR Morb Mortal Wkl... - April 16, 2016 Category: Epidemiology Authors: Singh T, Arrazola RA, Corey CG, Husten CG, Neff LJ, Homa DM, King BA Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Biologics Will Pump Up the Vasculitis Market.
Authors: Fellner C Abstract Vasculitis, a group of heterogeneous disorders characterized by inflammation and necrosis of the blood vessels, has but one treatment approved by the Food and Drug Administration. However, six novel biologic candidates are in late-stage development. PMID: 27069346 [PubMed] (Source: P and T)
Source: P and T - April 15, 2016 Category: Drugs & Pharmacology Tags: P T Source Type: research

Antifungal Drugs for Onychomycosis: Efficacy, Safety, and Mechanisms of Action.
Authors: Rosen T, Stein Gold LF Abstract In 1996, oral terbinafine joined itraconazole and fluconazole on the short list of systemic medications that could be used to treat onychomycosis (although fluconazole was not approved for this indication by the US Food and Drug Administration [FDA], it was commonly used for this purpose). In 1999, ciclopirox was the first topical treatment to be FDA approved. The addition of the topical antifungal agents efinaconazole and tavaborole in 2014 expanded the roster of medications available to more effectively manage onychomycosis in a wide range of patients, including those for ...
Source: Seminars in Cutaneous Medicine and Surgery - April 15, 2016 Category: Dermatology Tags: Semin Cutan Med Surg Source Type: research

Sulfasalazine impacts on ferroptotic cell death and alleviates the tumor microenvironment and glioma-induced brain edema.
Authors: Sehm T, Fan Z, Ghoochani A, Rauh M, Engelhorn T, Minakaki G, Dörfler A, Klucken J, Buchfelder M, Eyüpoglu IY, Savaskan NE Abstract The glutamate transporter xCT (SCL7a11, system Xc-, SXC) is an emerging key player in glutamate/cysteine/glutathione homeostasis in the brain and in cancer. xCT expression correlates with the grade of malignancy. Here, we report on the use of the U.S. Food and Drug Administration and EMA-approved xCT inhibitor, sulfasalazine (SAS) in gliomas. SAS does not affect cell viability in gliomas at concentrations below 200 µM. At higher concentrations SAS becomes gliomatoxic. Mechan...
Source: Oncotarget - April 15, 2016 Category: Cancer & Oncology Tags: Oncotarget Source Type: research

Aripiprazole Lauroxil Long-Acting Injectable: The Latest Addition to Second-Generation Long-Acting Agents.
Authors: Aggarwal A, Gopalakrishna G, Lauriello J Abstract Antipsychotics have long been the mainstay for the treatment of schizophrenia and other psychotic disorders. Long-acting injectables (LAI) of antipsychotics-provided once every two weeks to once every three months-promise to reduce the incidence of nonadherence. ARISTADA(™) (aripiprazole lauroxil; ALLAI) extended-release injectable suspension was approved by the U.S. Food and Drug Administration in October 2015 for the treatment of schizophrenia, and is the newest entrant in the LAI market. ALLAI is available as a single-use, pre-filled syringe, can be st...
Source: Clinical Schizophrenia and Related Psychoses - April 15, 2016 Category: Psychiatry Tags: Clin Schizophr Relat Psychoses Source Type: research

Chemoprevention of familial adenomatous polyposis
Abstract Familial adenomatous polyposis (FAP) has always been first and foremost a surgical disease, whose treatment with colectomy has long been known to reduce risk of premature cancer death. The notion of reducing polyp burden and potentially delaying surgical intervention has spawned a host of “chemoprevention” trials. In this paper I selectively review the findings from these studies, highlighting trial design issues and in particular some of the limitations of historical and existing trial endpoint measures. Nonsteroidal anti-inflammatory agents have been the most commonly employed chemopreventive agents...
Source: Familial Cancer - April 15, 2016 Category: Cancer & Oncology Source Type: research

Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
Abstract The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation a...
Source: International Journal of Hematology - April 15, 2016 Category: Hematology Authors: Nagai S, Ozawa K Tags: Int J Hematol Source Type: research

Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid. Final rule.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid. Final rule. Fed Regist. 2016 Apr 15;81(73):22176-83 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza. PMID: 27101640 [PubMed - in...
Source: Fed Regist - April 15, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Successful Anti-PD-1 Antibody Treatment in a Metastatic Melanoma Patient With Known Severe Autoimmune Disease
We report for the first time a successful treatment with a programmed death-1 antibody in a 69-year-old metastastic melanoma patient with a Churg-Strauss lung vasculitis and a prior ipilimumab-induced autoimmune colitis. This case report suggests that pembrolizumab can be given with caution to patients with underlying autoimmune disease. As the use of checkpoint inhibitors expands, knowledge about their safety in patients with underlying autoimmune diseases will become increasingly important, in particular because these patients are typically excluded from clinical trials with immune-checkpoint inhibitors. (Source: Journal of Immunotherapy)
Source: Journal of Immunotherapy - April 14, 2016 Category: Allergy & Immunology Tags: Clinical Studies Source Type: research

FDA Proposes New Rule to Ban Use of Indoor Tanning Devices by Minors
The US Food and Drug Administration (FDA) has proposed 2 new rules to protect consumers from health risks... (Source: Cutis: Cutaneous Medicine for the Practitioner)
Source: Cutis: Cutaneous Medicine for the Practitioner - April 14, 2016 Category: Dermatology Source Type: research

Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
Pivotal trials, the clinical studies that inform U.S. Food and Drug Administration (FDA) approval decisions, provide the foundational evidence supporting the safety and efficacy of novel therapeutics. We deter... (Source: Trials)
Source: Trials - April 14, 2016 Category: Journals (General) Authors: Nicholas S. Downing, Nilay D. Shah, Joseph H. Neiman, Jenerius A. Aminawung, Harlan M. Krumholz and Joseph S. Ross Source Type: research