Food and Drug Administration (FDA) Food and Drug Administration (FDA) RSS feedThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

This page shows you the latest research publications in this category.

Novel Trans Fat Replacement Strategies
This article reviews novel strategies to structure liquid oils as PHO alternatives. The oil structuring mechanisms of ethylcellulose oleogels, plant-based wax oleogels, and monoglyceride-structured emulsions are discussed in detail. The structural and mechanical properties of such systems can be tailored to mimic that of PHO based fat systems. These oil-structuring methods show promising application in PHO-free products. Graphical abstract (Source: Current Opinion in Food Science)
Source: Current Opinion in Food Science - August 29, 2015 Category: Food Science Source Type: research

The value of magnetic resonance imaging and ultrasonography (MRI/US)‐fusion biopsy platforms in prostate cancer detection: a systematic review
Despite limitations considering the presence, staging and aggressiveness of prostate cancer, ultrasonography (US)‐guided systematic biopsies (SBs) are still the ‘gold standard’ for the diagnosis of prostate cancer. Recently, promising results have been published for targeted prostate biopsies (TBs) using magnetic resonance imaging (MRI) and ultrasonography (MRI/US)‐fusion platforms. Different platforms are USA Food and Drug Administration registered and have, mostly subjective, strengths and weaknesses. To our knowledge, no systematic review exists that objectively compares prostate cancer detection rates between t...
Source: BJU International - August 28, 2015 Category: Urology & Nephrology Authors: Maudy Gayet, Anouk Aa, Harrie P. Beerlage, Bart Ph. Schrier, Peter F.A. Mulders, Hessel Wijkstra Tags: Commissioned Review Source Type: research

[In Brief] This week's section
In science news around the world, the IS group destroys an ancient temple in Palmyra, Syria, the U.S. Food and Drug Administration approves a "female Viagra" drug, eight protestors are arrested in Hawaii attempting to block construction of the Daniel K. Inouye Solar Telescope, a new quantum processor breaks the "1000-qubit barrier," and more. Also, the National Oceanic and Atmospheric Administration declares the deaths of 30 large whales in the Gulf of Alaska since May an "unusual mortality event," triggering a focused investigation into the cause of the deaths. And Science chats with Jorge Cham, creator of the comic Piled...
Source: Science: Current Issue - August 28, 2015 Category: Science Authors: Science Magazine (mailto:soleditor at aaas.org) Source Type: research

Auto‐immune arthropathy and uveitis as complications from PD‐1 inhibitor
This article is protected by copyright. All rights reserved. (Source: Arthritis and Rheumatism)
Source: Arthritis and Rheumatism - August 28, 2015 Category: Rheumatology Authors: Guillermo de Velasco, Boonie Bermas, Toni K. Choueiri Tags: Clinical Image Source Type: research

Cancers, Vol. 7, Pages 1684-1698: Non-Canonical Hh Signaling in Cancer—Current Understanding and Future Directions
As a major regulatory pathway for embryonic development and tissue patterning, hedgehog signaling is not active in most adult tissues, but is reactivated in a number of human cancer types. A major milestone in hedgehog signaling in cancer is the Food and Drug Administration (FDA) approval of a smoothened inhibitor Vismodegib for treatment of basal cell carcinomas. Vismodegib can block ligand-mediated hedgehog signaling, but numerous additional clinical trials have failed to show significant improvements in cancer patients. Amounting evidence indicate that ligand-independent hedgehog signaling plays an essential role in can...
Source: Cancers - August 27, 2015 Category: Cancer & Oncology Authors: Dongsheng GuJingwu Xie Tags: Review Source Type: research

Update on the treatment of orthostatic hzypotension
Neurogenic orthostatic hypotension (nOH) is a fall in blood pressure on standing due to impaired norepinephrine release from post-ganglionic sympathetic neurons. nOH may cause disabling hypoperfusion of the brain and other tissues. Non-pharmacological measures are the first line of treatment and include pressure garments and new types of abdominal binders. Pharmacological approaches include intravascular volume expansion and pressor agents. Recently, large, international phase 3 clinical trials of droxidopa (Northera®) an artificial aminoacid converted to norepinephrine by dopa decarboxylase, showed significant symptomati...
Source: Autonomic Neuroscience: Basic and Clinical - August 26, 2015 Category: Neuroscience Authors: Horacio Kaufmann Tags: 24.3 Source Type: research

Three POCT Molecular Applications: A View Into Future Development
Abstract: Molecular diagnostic tests consist of 3 processes: extraction/purification of nucleic acid, amplification of specific target region, and finally detection of amplified products. For Point of Care Testing applications, these 3 steps need to be miniaturized using microfluidics to reduce reagent volumes and associated costs. Extraction may be eliminated if Polymerase Chain Reaction enhancers are added and if mutated/modified DNA polymerase are used, which are resistant to polymerase inhibitors. Numerous proof of concept devices have been reported for molecular diagnostic assays, and some are Food and Drug Administra...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - August 26, 2015 Category: Pathology Tags: Review Articles Source Type: research

Protein/peptide‐based entry/fusion inhibitors as anti‐HIV therapies: challenges and future direction
Summary The failures of several first‐generation and second‐generation small molecule drug‐based anti‐HIV therapies in various stages of clinical trials are an indication that there is a need for a paradigm shift in the future designs of anti‐HIV therapeutics. Over the past several decades, various anti‐HIV drugs have been developed, among them, protein/peptide‐based therapies. From the first peptide discovered (SJ2176) to the first peptide approved by the Food and Drug Administration (DP178/T20/enfuvirtide/Fuzeon®), anti‐HIV proteins/peptides as fusion/entry inhibitors have been shown to provide potent ef...
Source: Reviews in Medical Virology - August 26, 2015 Category: Virology Authors: Miral Fumakia, Sidi Yang, Jijin Gu, Emmanuel A. Ho Tags: Review Source Type: research

NIEHS/FDA CLARITY-BPA research program update
Publication date: December 2015 Source:Reproductive Toxicology, Volume 58 Author(s): Jerrold J. Heindel, Retha R. Newbold, John R. Bucher, Luísa Camacho, K. Barry Delclos, Sherry M. Lewis, Michelle Vanlandingham, Mona I. Churchwell, Nathan C. Twaddle, Michelle McLellen, Mani Chidambaram, Matthew Bryant, Kellie Woodling, Gonçalo Gamboa da Costa, Sherry A. Ferguson, Jodi Flaws, Paul C. Howard, Nigel J. Walker, R. Thomas Zoeller, Jennifer Fostel, Carolyn Favaro, Thaddeus T. Schug Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human ex...
Source: Reproductive Toxicology - August 25, 2015 Category: Toxicology Source Type: research

Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders
We examined a large physician database for impact of the warning on antidepressant prescriptions, suicidality and other aggressive behaviors in major depressive disorder (MDD) and anxiety disorders in adult and pediatric patients. We analyzed electronic database covering over 100,000 patients, treated in Pre- (before 2003) and Post- (after 2004) warning periods. We compared strength of the association between the measures and the time period with two tests. Multivariate logistic regression analyses were performed to ascertain the unique effect of each parameter. Of 10,089 MDD (61.0 %) and anxiety disorders (39.0 %) patie...
Source: Psychiatric Quarterly - August 25, 2015 Category: Psychiatry Source Type: research

Analytical and statistical comparability of generic enoxaparins from the US market with the originator product
In this study, samples from several batches of generic enoxaparins were purchased on the US market and analyzed with state of the art methodologies, including disaccharide building blocks quantification, nuclear magnetic resonance (NMR), and a combination of orthogonal separation techniques. Direct high-performance liquid chromatography analysis of the different enoxaparin batches revealed distinct process fingerprints associated with each manufacturer. Disaccharide building block analysis showed differences in the degree of sulfation, the presence of glycoserine derivatives, as well as in proportions of disaccharides. Res...
Source: Journal of Pharmaceutical and Biomedical Analysis - August 25, 2015 Category: Drugs & Pharmacology Source Type: research

Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014
This report will review potential approaches to enhancing neonatal drug development. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Offringa, M., Davis, J. M., Turner, M. A., Ward, R., Bax, R., Maldonado, S., Sinha, V., McCune, S. K., Zajicek, A., Benjamin, D. K., Bucci-Rechtweg, C., Nelson, R. M. Tags: Special Section on Pediatrics Source Type: research

Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients
Many drugs approved by the US Food and Drug Administration (FDA) for use in adults lack adequate data on safety and efficacy in pediatric patients, a potential source of unintended harm to pediatric patients. Through a series of laws, regulations, and guidance documents, the US Congress and FDA have created a program both to encourage and mandate clinical studies in pediatric patients to develop evidence-based dosing, safety, and efficacy information. A "Pediatric Study Plan" (PSP) is required for every new drug. FDA provides incentives for the voluntary conduct of clinical trials in pediatric patients, including opportuni...
Source: Therapeutic Innovation and Regulatory Science - August 25, 2015 Category: Drugs & Pharmacology Authors: Tabor, E. Tags: Special Section on Pediatrics Source Type: research

FDA approves Rexulti to treat schizophrenia and as an add‐on to an antidepressant to treat major depressive disorder
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add‐on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD). (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - August 25, 2015 Category: Psychiatry Tags: From the FDA Source Type: research

Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation
Obinutuzumab (also known as GA101, afutuzumab, Gazyva) is a humanized, glycoengineered type II monoclonal antibody targeted against CD20. The US Food and Drug Administration has approved obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first treatment to receive approval under the agency's breakthrough therapy designation, a program intended to facilitate and expedite the review and development of therapies for serious and life-threatening conditions. In preclinical studies, obinutuzumab has showed superior efficacy, as compared with rituximab, ...
Source: Journal of Oncology Pharmacy Practice - August 25, 2015 Category: Cancer & Oncology Authors: Kakkar, A. K., Balakrishnan, S. Tags: Review Articles Source Type: research

Practice Patterns and Postoperative Complications Before and After Food and Drug Administration Safety Communication on Power Morcellation
In April 2014, the U.S. Food and Drug Administration (FDA) published its first safety communication discouraging “the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.” Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leoimyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the US. (Source: American Journal of Obstetrics and Gynecology)
Source: American Journal of Obstetrics and Gynecology - August 24, 2015 Category: OBGYN Authors: John A. Harris, Carolyn W. Swenson, Shitanshu Uppal, Neil Kamdar, Nichole Mahnert, Sawsan As-Sanie, Daniel M. Morgan Source Type: research

Practice Bulletin Summary No. 152: Emergency Contraception.
Authors: Abstract Emergency contraception, also known as postcoital contraception, is therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse. Common indications for emergency contraception include contraceptive failure (eg, condom breakage or missed doses of oral contraceptives) and failure to use any form of contraception (1-3). Although oral emergency contraception was first described in the medical literature in the 1960s, the U.S. Food and Drug Administration (FDA) approved the first dedicated product for emergency contraception in 1998. Since then, several n...
Source: Obstetrics and Gynecology - August 23, 2015 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Committee Opinion Summary No. 641: Human Papillomavirus Vaccination.
Authors: Abstract Human papillomavirus (HPV) is associated with the development of anogenital cancer (including cervical, vaginal, vulvar, penile, and anal), oropharyngeal cancer, and genital warts. Human papillomavirus vaccination can significantly reduce the incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only approximately one third of girls in the recommended age group have received all three vaccines. Compared with other vaccines recommended in the same age bracket, HPV vaccination rates in the United States are unacceptably low. It is crucial that obstetrician-gynecolo...
Source: Obstetrics and Gynecology - August 23, 2015 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Practice Bulletin No. 152: Emergency Contraception.
Authors: Abstract Emergency contraception, also known as postcoital contraception, is therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse. Common indications for emergency contraception include contraceptive failure (eg, condom breakage or missed doses of oral contraceptives) and failure to use any form of contraception (). Although oral emergency contraception was first described in the medical literature in the 1960s, the U.S. Food and Drug Administration (FDA) approved the first dedicated product for emergency contraception in 1998. Since then, several new ...
Source: Obstetrics and Gynecology - August 23, 2015 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Committee Opinion No. 641: Human Papillomavirus Vaccination.
Authors: Abstract Human papillomavirus (HPV) is associated with the development of anogenital cancer (including cervical, vaginal, vulvar, penile, and anal), oropharyngeal cancer, and genital warts. Human papillomavirus vaccination can significantly reduce the incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only approximately one third of girls in the recommended age group have received all three vaccines. Compared with other vaccines recommended in the same age bracket, HPV vaccination rates in the United States are unacceptably low. It is crucial that obstetrician-gynecolo...
Source: Obstetrics and Gynecology - August 23, 2015 Category: OBGYN Tags: Obstet Gynecol Source Type: research

TPMT Testing Before Starting Azathioprine or Mercaptopurine: Surely Just Do It?
Across every field of clinical medicine, there are now multiple examples of how genetic variation between individuals can have an important influence on the response—adverse or favorable—to a specific class of drug. This concept is known as pharmacogenomics, a field which has expanded massively over the last 20 years. Indeed, >150 drugs approved by the US Food and Drug Administration have a recommendation regarding pharmacogenetic variation included in the official drug labeling.1 Despite this, the uptake of pretreatment pharmacogenetic testing into routine clinical practice remains remarkably low. (Source: Gastroenterology)
Source: Gastroenterology - August 23, 2015 Category: Gastroenterology Authors: Jeremy D. Sanderson Tags: Editorial Source Type: research

Immune Checkpoint Inhibitors for Cancer Therapy: Clinical Efficacy and Safety.
Abstract A major breakthrough in cancer immunotherapy was the discovery of immune checkpoint proteins, which function to effectively inhibit the immune system through various mechanisms. The first of such molecules shown to inhibit both T-cell proliferation and IL-2 production was cytotoxic T-lymphocyte associated protein 4 (CTLA-4). With this discovery, efforts turned to blocking this inhibitory pathway in an attempt to activate dormant T-cells directed at cancer cells. The first antibody directed against CTLA-4, ipilimumab, was quickly ushered into clinical trials and was approved by the US Food and Drug Administ...
Source: Current Cancer Drug Targets - August 21, 2015 Category: Cancer & Oncology Authors: Azoury SC, Straughan DM, Shukla V Tags: Curr Cancer Drug Targets Source Type: research

Persistent alterations of gene expression profiling of human peripheral blood mononuclear cells from smokers
The number of validated biomarkers of tobacco smoke exposure is limited, and none exist for tobacco‐related cancer. Additional biomarkers for smoke, effects on cellular systems in vivo are needed to improve early detection of lung cancer, and to assist the Food and Drug Administration in regulating exposures to tobacco products. We assessed the effects of smoking on the gene expression using human cell cultures and blood from a cross‐sectional study. We profiled global transcriptional changes in cultured smokers’ peripheral blood mononuclear cells (PBMCs) treated with cigarette smoke condensate (CSC) in vitro (n =...
Source: Molecular Carcinogenesis - August 21, 2015 Category: Molecular Biology Authors: Daniel Y. Weng, Jinguo Chen, Cenny Taslim, Ping‐Ching Hsu, Catalin Marian, Sean P. David, Christopher A. Loffredo, Peter G. Shields Tags: Research Article Source Type: research

Website Review: Review of Patient-Oriented Websites on Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) is characterized by esophageal dysfunction and esophageal eosinophilia refractory to proton pump inhibitor treatment. EoE is increasing in prevalence and there is currently no treatment approved by the US Food and Drug Administration. Management recommendation is based primarily on clinical experience, case series, and small controlled trials. It includes various dietary, pharmacologic, and endoscopic interventions. Optimal treatment regimen depends on local expertise, patient comorbidities, and preferences. (Source: Gastroenterology)
Source: Gastroenterology - August 21, 2015 Category: Gastroenterology Authors: Nikola Natov, John Leung Tags: Print and Digital Media Review Source Type: research

Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)
This article is protected by copyright. All rights reserved (Source: Journal of Bone and Mineral Research)
Source: Journal of Bone and Mineral Research - August 20, 2015 Category: Orthopaedics Authors: Xiaoyan Zhang, Issam S. Hamadeh, Shuang Song, Lawrence J. Lesko, Yan Gong Tags: Original Article Source Type: research

Propofol: A Review of its Role in Pediatric Anesthesia and Sedation
Abstract Propofol is an intravenous agent used commonly for the induction and maintenance of anesthesia, procedural, and critical care sedation in children. The mechanisms of action on the central nervous system involve interactions at various neurotransmitter receptors, especially the gamma-aminobutyric acid A receptor. Approved for use in the USA by the Food and Drug Administration in 1989, its use for induction of anesthesia in children less than 3 years of age still remains off-label. Despite its wide use in pediatric anesthesia, there is conflicting literature about its safety and serious adverse effects in ...
Source: CNS Drugs - August 20, 2015 Category: Neurology Source Type: research

Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials
A recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss imaging endpoints for clinical trials in glioblastoma. This workshop developed a set of priorities and action items including the creation of a standardized MRI protocol for multicenter studies. The current document outlines consensus recommendations for a standardized Brain Tumor Imaging Protocol (BTIP), along with the scientific and practica...
Source: Neuro-Oncology - August 20, 2015 Category: Cancer & Oncology Authors: Ellingson, B. M., Bendszus, M., Boxerman, J., Barboriak, D., Erickson, B. J., Smits, M., Nelson, S. J., Gerstner, E., Alexander, B., Goldmacher, G., Wick, W., Vogelbaum, M., Weller, M., Galanis, E., Kalpathy-Cramer, J., Shankar, L., Jacobs, P., Pope, W. B Tags: Reviews Source Type: research

Treating patients with ALK-positive non-small cell lung cancer: latest evidence and management strategy
Rearrangements in anaplastic lymphoma kinase (ALK) gene and echinoderm microtubule-associated protein-like 4 (EML4) gene were first described in a small portion of patients with non-small cell lung cancer (NSCLC) in 2007. Fluorescence in situ hybridization is used as the diagnostic test for detecting an EML4–ALK rearrangement. Crizotinib, an ALK inhibitor, is effective in treating advanced ALK-positive NSCLC, and the US Food and Drug Administration approved it for treating ALK-positive NSCLC in 2011. Several mechanisms of acquired resistance to crizotinib have recently been reported. Second-generation ALK inhibitors ...
Source: Therapeutic Advances in Medical Oncology - August 20, 2015 Category: Cancer & Oncology Authors: Liao, B.-C., Lin, C.-C., Shih, J.-Y., Yang, J. C.-H. Tags: Reviews Source Type: research

Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act. Final order.
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act. Final order. Fed Regist. 2015 Aug 20;80(161):50559-64 Authors: Food and Drug Administration, HHS Abstract The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansio...
Source: Fed Regist - August 20, 2015 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Chinese Medicine in Inhalation Therapy: A Review of Clinical Application and Formulation Development.
Abstract Chinese medicine (CM) in inhalation therapy has a long history of applications since ancient China in the forms of smoke, steam vapor, medicated pillows and aromatic sachets. Over the years, thousands of clinical treatments involving the inhalation of CMs have been reported for the treatment of respiratory disease. Shuanghuanglian, Yuxingcao and Qingkailing are primarily applied in pneumonia and bronchitis. At present, metered dose inhalation (MDI), aromatic inhalation and nebulized inhalation are used extensively in practice. In particular, nebulized CM for the treatment of respiratory diseases has been a...
Source: Current Pharmaceutical Design - August 20, 2015 Category: Drugs & Pharmacology Authors: Miao X, Zhou J, Li J, Liao Y, Zheng Y Tags: Curr Pharm Des Source Type: research

Recognition and Management of Oral Mucosal Injury Caused by Mammalian Target of Rapamycin Inhibitors: A Case Series
We report three cases that illustrate the complexity involved in the early assessment, referral, and appropriate management of mTORI-associated oral mucosal injury. Corticosteroids appear to be very useful in managing and perhaps preventing these lesions, whereas this approach has never shown efficacy in conventional chemotherapy-related mucositis. Early intervention to reduce the mTORI-associated oral mucosal injury is important to diminish the need for dose alterations of mTORIs and, therefore, to improve patient outcomes.Case Rep Oncol 2015;8:369-377 (Source: Case Reports in Oncology)
Source: Case Reports in Oncology - August 19, 2015 Category: Cancer & Oncology Source Type: research

Clinical implications of omics and systems medicine: focus on predictive and individualized treatment
Abstract Many patients with common diseases do not respond to treatment. This is a key challenge to modern health care, which causes both suffering and enormous costs. One important reason for the lack of treatment response is that common diseases are associated with altered interactions between thousands of genes, in combinations that differ between subgroups of patients who do or do not respond to a given treatment. Such subgroups, or even distinct disease entities, have been described recently in asthma, diabetes, autoimmune diseases and cancer. High‐throughput techniques (omics) allow identification and characterizat...
Source: Journal of Internal Medicine - August 19, 2015 Category: Internal Medicine Authors: M. Benson Tags: Review Source Type: research

The β‐Lactams Strike Back: Ceftazidime‐Avibactam
Gram‐negative resistance has reached a crucial point, with emergence of pathogens resistant to most or all available antibiotics. Ceftazidime‐avibactam is a newly approved agent combining ceftazidime and a novel β‐lactamase inhibitor with activity against multidrug‐resistant gram‐negative bacteria. Avibactam has increased potency and expanded spectrum of inhibition of class A and C β‐lactamases relative to available β‐lactamase inhibitors, including extended‐spectrum β‐lactamases, AmpC, and Klebsiella pneumoniae carbapenemase (KPC) enzymes. Avibactam expands ceftazidime's spectrum of activity to inclu...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - August 19, 2015 Category: Drugs & Pharmacology Authors: Evan J. Zasowski, Jeffrey M. Rybak, Michael J. Rybak Tags: Reviews of Therapeutics Source Type: research

HeartWare Ventricular Assist Device Placement in a Patient With Corrected Dextro-Transposition of Great Arteries: A Case Report and Its Clinical Challenges
Given the improved survival in patients with corrected dextro-transposition of great arteries (D-TGA), it has evolved into an adult congenital heart defect. It is important to understand the management and complications observed in this population that eventually progresses to systemic ventricular failure requiring cardiac transplantation. Our case focuses on the rapid right ventricle (RV) deterioration of a patient with corrected D-TGA following a surgical procedure requiring systemic support. With such patients awaiting heart transplantation, there are limited assist devices available for RV support and no right ventricu...
Source: Seminars in Cardiothoracic and Vascular Anesthesia - August 18, 2015 Category: Anesthesiology Authors: Sehgal, S., Ramachandran, S., Leff, J. D. Tags: Clinical Challenge Source Type: research

Point-Counterpoint: Cervical Cancer Screening Should Be Done by Primary Human Papillomavirus Testing with Genotyping and Reflex Cytology for Women over the Age of 25 Years [Point-Counterpoint]
Screening for cervical cancer with cytology testing has been very effective in reducing cervical cancer in the United States. For decades, the approach was an annual Pap test. In 2000, the Hybrid Capture 2 human papillomavirus (HPV) test was approved by the U.S. Food and Drug Administration (FDA) for screening women who have atypical squamous cells of underdetermined significance (ASCUS) detected by Pap test to determine the need for colposcopy. In 2003, the FDA approved expanding the use of the test to include screening performed in conjunction with a Pap test for women over the age of 30 years, referred to as "cotesting....
Source: Journal of Clinical Microbiology - August 18, 2015 Category: Microbiology Authors: Stoler, M. H., Austin, R. M., Zhao, C. Tags: Point-Counterpoint Source Type: research

Pembrolizumab
Abstract The development of the cytotoxic T-lymphocyte-associated protein 4 inhibitor ipilimumab and its approval in 2011 for the treatment of metastatic melanoma has heralded a new era in immuno-oncology. Subsequently, novel agents against the programmed death receptor 1 (PD-1)/programmed death receptor ligand 1 (PD-L1) axis have shown significant activity in melanoma and a variety of other tumor types. Pembrolizumab was the first anti-PD-1 antibody to be approved by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with disease progression following ipili...
Source: Journal for Immunotherapy of Cancer - August 18, 2015 Category: Cancer & Oncology Source Type: research

Molecular cancer prevention: Current status and future directions.
Abstract Answer questions and earn CME/CNE The heterogeneity and complexity of advanced cancers strongly support the rationale for an enhanced focus on molecular prevention as a priority strategy to reduce the burden of cancer. Molecular prevention encompasses traditional chemopreventive agents as well as vaccinations and therapeutic approaches to cancer-predisposing conditions. Despite challenges to the field, we now have refined insights into cancer etiology and early pathogenesis; successful risk assessment and new risk models; agents with broad preventive efficacy (eg, aspirin) in common chronic diseases, inclu...
Source: Clinical Genitourinary Cancer - August 18, 2015 Category: Cancer & Oncology Authors: Maresso KC, Tsai KY, Brown PH, Szabo E, Lippman S, Hawk ET Tags: CA Cancer J Clin Source Type: research

Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device. Final order.
Abstract The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 26292372 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - August 18, 2015 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
Abstract PURPOSE: Our aim was to describe the regulatory pathways made available by the US Food and Drug Administration (FDA) to expedite the drug development and approval process, with a focus on the benefits and limitations of the Breakthrough Therapy Designation (BTD) pathway. METHODS: Published materials consisting of journal articles, press releases, government documents, and news articles from pharmaceutical publishers were identified through online databases (ie, Medline and Scopus), the FDA website, and Internet search engines (eg, Google). FINDINGS: To encourage pharmaceutical innovation and increa...
Source: Clinical Therapeutics - August 18, 2015 Category: Drugs & Pharmacology Authors: Kwok M, Foster T, Steinberg M Tags: Clin Ther Source Type: research

Health Canada's use of priority review status for drugs for unmet needs
This study compared new therapeutic drugs approved by both Health Canada and the Food and Drug Administration (FDA) between 2000 and 2014 to evaluate concordance on priority review status. New therapeutic drugs approved in both countries totalled 301; 86 (28.6%) and 136 (45.2%) were given priority review status in Canada and the United States, respectively, with 73 (24.3%) in both. Sensitivity and specificity were 53.7% and 92.1%. Overall concordance on review type was 74.8%. κ was 0.47 indicating moderate agreement. Agreement on review type was >70% for all drugs, except oncology therapies. Broad agreement exists ...
Source: Regulatory Toxicology and Pharmacology - August 17, 2015 Category: Toxicology Source Type: research

Medical marijuana: Between a plant and a hard place
Medical marijuana (MMJ) is a multifaceted and complicated issue involving far too much information to convey in a single review article. In this article, we touch on points that we hope will help the practitioner make more informed decisions about the use of MMJ in the field of neurology. In particular, we discuss the systematic review published in Neurology® and describe the 2 agents that have been approved for general use by the US Food and Drug Administration (FDA). In addition, we address quality assurance, prescribing, and legal concerns and provide information about the use of Epidiolex, a liquid formulation of h...
Source: Nature Clinical Practice - August 17, 2015 Category: Neurology Authors: Gloss, D. S., Maa, E. H. Tags: Guideline Perspective Source Type: research

The US Food and Drug Administration, neurologists, and drug development and regulation
The US Food and Drug Administration (FDA) plays a vital role in the regulation of human drugs and therapeutic biologics. Most physicians, while aware of the broad reach of the FDA, are unaware of what the agency actually does and how it does it. Practicing neurologists should be aware of the role neurologists can play in drug development, the informational resources that the FDA provides to practitioners, and the process of submitting reports of suspected adverse drug reactions to the FDA. (Source: Nature Clinical Practice)
Source: Nature Clinical Practice - August 17, 2015 Category: Neurology Authors: Dal Pan, G. J. Tags: Harm/ risk (analysis), All Clinical trials, All epidemiology Eye on Practice Source Type: research

Blinatumomab for the Treatment of Philadelphia Chromosome-Negative, Precursor B-cell Acute Lymphoblastic Leukemia.
Abstract Blinatumomab is a CD19/CD3-bispescific antibody designed to redirect T-cells towards malignant B-cells and induce their lysis. It recently gained accelerated approval by the Food and Drug Administration for the treatment of relapsed or refractory Philadelphia chromosome-negative B-cell ALL (RR-ALL). In the phase II trial that served as the basis for approval, blinatumomab demonstrated significant single agent activity and induced remission (complete remission (CR) and CR with incomplete recovery of peripheral blood counts (CRh)) in 43% of 189 adult patients with RR-ALL; the majority of responders (82%) als...
Source: Clinical Cancer Research - August 17, 2015 Category: Cancer & Oncology Authors: Wolach O, Stone RM Tags: Clin Cancer Res Source Type: research

Old tyrosine kinase inhibitors and newcomers in gastrointestinal cancer treatment.
Abstract Gastrointestinal cancer treatment is being based more and more on molecular biology, that has provided an increasing knowledge about cancer pathogenesis on which developing targeted therapy. Precisely, targeted therapy is defined a "type of treatment that uses drugs, such as monoclonal antibodies or tyrosine kinase inhibitors, to identify and attack specific cancer cells". Nowadays, many targeted therapies have been approved by the United States Food and Drug Administration for gastrointestinal cancers treatment, as many are in various phases of development as well. In a previous review we discussed the ma...
Source: Current Cancer Drug Targets - August 17, 2015 Category: Cancer & Oncology Authors: Erika G, Federica Z, Martina S, Anselmo P, Luigi R, Marina M, Davide C, Eleonora Z, Monica V, Silverio T Tags: Curr Cancer Drug Targets Source Type: research

Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid. Final order.
Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid. Final order. Fed Regist. 2015 Aug 17;80(158):49136-8 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is classifying the computerized cognitive assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the computerized cognitive assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to prov...
Source: Fed Regist - August 17, 2015 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Changing Contraindications for t-PA in Acute Stroke: Review of 20 Years Since NINDS
Abstract When intravenous (IV) tissue-type plasminogen activator (t-PA) was originally approved by the Food and Drug Administration (FDA) for acute ischemic stroke (AIS) in 1996, there was a lengthy list of contraindications. In the 19 years since the approval of t-PA for AIS, it has been used off label and in patients with those contraindications. In February 2015, the list of contraindications for IV t-PA in AIS was revised and several of the previous contraindications were removed. As only 4 % of patients with ischemic stroke receive treatment with IV t-PA, these changes increase the number of patients eligi...
Source: Current Cardiology Reports - August 16, 2015 Category: Cardiology Source Type: research

Validity of the Hochberg procedure revisited for clinical trial applications
This article is a U.S. Government work and is in the public domain in the USA. (Source: Statistics in Medicine)
Source: Statistics in Medicine - August 16, 2015 Category: Statistics Authors: Mohammad F. Huque Tags: Research Article Source Type: research

Targeting the platelet-derived growth factor signaling in cardiovascular disease.
This article is protected by copyright. All rights reserved. PMID: 26277708 [PubMed - as supplied by publisher] (Source: Clinical and Experimental Pharmacology and Physiology)
Source: Clinical and Experimental Pharmacology and Physiology - August 16, 2015 Category: Drugs & Pharmacology Authors: Hu W, Huang Y Tags: Clin Exp Pharmacol Physiol Source Type: research

Treatment of Peripheral T-Cell Lymphoma: Many Shades of Gray.
Abstract Previously obscured within other designations of aggressive lymphomas, peripheral T-cell lymphoma (PTCL) now represents 23 different subtypes of non-Hodgkin lymphoma (NHL). Despite the many subtypes now recognized, PTCL represents only approximately 10% of all NHL cases diagnosed. Positron emission tomography/computed tomography has become essential to accurate staging and response-evaluation for PTCL. In comparison to aggressive B-cell NHL, patients with PTCL will more often be refractory to initial therapy, and chemosensitive patients will have shorter disease-free periods. Anthracycline-based regimens, ...
Source: Oncology (Williston Park, N.Y.) - August 15, 2015 Category: Cancer & Oncology Authors: Lunning MA Tags: Oncology (Williston Park) Source Type: research

Infant risk of pulmonary hypertension from maternal antidepressants appears small
A new cohort study examining Medicaid‐insured pregnant women has found a smaller risk of persistent pulmonary hypertension of the newborn (PPHN) from women's late‐term use of antidepressants than what had been seen in earlier research. The latest findings add further context to a topic that has been greatly discussed since the Food and Drug Administration (FDA) in 2006 issued a public health advisory on PPHN risk associated with late exposure to selective serotonin reuptake inhibitors (SSRIs). Study results were published June 2, 2015, in the Journal of the American Medical Association. (Source: The Brown University Ps...
Source: The Brown University Psychopharmacology Update - August 14, 2015 Category: Psychiatry Tags: Antidepressant Treatment Source Type: research