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Instructions for Authors
All submissions to Arthroscopy: The Journal of Arthroscopic and Related Surgery must comply with these Instructions for Authors. Studies should be in compliance with human studies committees and animal welfare regulations at the authors’ institutions and also in compliance with Food and Drug Administration guidelines. All manuscripts will be subject to peer review. Letters to the Editor and comments on the Journal’s content or policies are always welcome and encouraged. (Source: Arthroscopy - Journal of Arthroscopic and Related Surgery)
Source: Arthroscopy - Journal of Arthroscopic and Related Surgery - July 31, 2015 Category: Surgery Source Type: research

Practical considerations in the pharmacologic treatment of idiopathic pulmonary fibrosis
Purpose of review: Idiopathic pulmonary fibrosis (IPF) is a progressive and deadly disease. The US Food and Drug Administration recently approved two medications for the treatment of IPF – pirfenidone and nintedanib. Given the limited clinical experience with these agents, a number of questions remain regarding their use. Recent findings: Both pirfenidone and nintedanib were demonstrated to reduce the rate of decline in forced vital capacity in independent large, double-blind, randomized controlled clinical trials. The successful implementation of both agents in clinical practice is dependent on many factors, including w...
Source: Current Opinion in Pulmonary Medicine - July 31, 2015 Category: Respiratory Medicine Tags: INTERSTITIAL LUNG DISEASE: Edited Francesco Bonnella and Steven D. Nathan Source Type: research

Predictable And SuStainable Implementation Of National Cardiovascular Registries Infrastructure: A Think Tank Report from MDEpiNet
This article summarizes the discussions at the meeting and the future directions of the PASSION program. (Source: American Heart Journal)
Source: American Heart Journal - July 31, 2015 Category: Cardiology Source Type: research

FDA approvals for the first 6 months of 2015
Nature Reviews Drug Discovery 14, 517 (2015). doi:10.1038/nrd4703 Author: Asher Mullard The US Food and Drug Administration (FDA) approved 14 new drugs in the first 6 months of this year (Table 1). These Center for Drug Evaluation and Research (CDER) approvals comprised 11 approvals for small molecules and 3 for biologics.FDA approvals tend (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - July 31, 2015 Category: Drugs & Pharmacology Authors: Asher Mullard Tags: News and Analysis Source Type: research

Ponatinib as first-line treatment for patients with chronic myeloid leukaemia in chronic phase: a phase 2 study
Publication date: Available online 30 July 2015 Source:The Lancet Haematology Author(s): Preetesh Jain, Hagop Kantarjian, Elias Jabbour, Graciela Nogueras Gonzalez, Gautam Borthakur, Naveen Pemmaraju, Naval Daver, Evguenia Gachimova, Alessandra Ferrajoli, Steven Kornblau, Farhad Ravandi, Susan O'Brien, Jorge Cortes Background Ponatinib has shown efficacy in patients with refractory chronic myeloid leukaemia (CML) and in those with CML with a Thr315Ile mutation. We aimed to investigate the activity and safety of ponatinib as first-line treatment for patients with chronic-phase CML. Methods We did a single-ar...
Source: The Lancet Haematology - July 31, 2015 Category: Hematology Source Type: research

Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China
Publication date: July 2015 Source:Chinese Journal of Natural Medicines, Volume 13, Issue 7 Author(s): Yu JIANG, Jun-Ping XIA, Jian-Hong YANG, Zhe-Feng ZHANG, Chang-Qin HU, Zhi-Rong ZHANG In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Ch...
Source: Chinese Journal of Natural Medicines - July 31, 2015 Category: Complementary Medicine Source Type: research

Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial
Publication date: Available online 30 July 2015 Source:The Lancet Neurology Author(s): DiPALS Writing CommitteeDiPALS Study Group Collaborators Background Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis (ALS). The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS. We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to...
Source: The Lancet Neurology - July 31, 2015 Category: Neurology Source Type: research

How I treat adults with relapsed or refractory Philadelphia chromosome-negative acute lymphoblastic leukemia
The long-term prognosis of adult patients with relapsed Philadelphia chromosome–negative acute lymphoblastic lymphoma (ALL) is poor. Allogeneic stem cell transplant in second remission is the only curative approach and is the goal when feasible. There is no standard chemotherapy regimen for relapsed disease, although a few agents are approved for use in this setting. The bispecific CD19-directed CD3 T-cell engager, blinatumomab, has recently been granted accelerated approval by the US Food and Drug Administration for relapsed or refractory disease of B-cell lineage. For patients with relapsed T-cell ALL, nelarabine i...
Source: Blood - July 30, 2015 Category: Hematology Authors: Frey, N. V., Luger, S. M. Tags: How I Treat, Free Research Articles, Lymphoid Neoplasia Source Type: research

Successful hemostasis and reversal of highly elevated PT/INR after dabigatran etexilate use in a patient with acute kidney injury
Dabigatran etexilate is a novel oral anticoagulant (NOAC) indicated for anticoagulation in the management of atrial fibrillation and venous thromboembolism. Prior to its approval by the United States Food and Drug administration, warfarin, a vitamin K antagonist, was one of few oral anticoagulant options. The burden of therapeutic drug monitoring, dietary restrictions, and various drug interactions associated with warfarin have countered its extensive history of efficacy. Although dabigatran etexilate may alleviate some concerns encountered with warfarin therapy, there remains a paucity of evidence surrounding emergent rev...
Source: The American Journal of Emergency Medicine - July 29, 2015 Category: Emergency Medicine Authors: Justin M. Jones, Heather M. Ryan, Mark Tieszen, David D. Leedahl Tags: Case Report Source Type: research

The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building: Legal Strategies for State Action
This article reviews studies reporting on Americans' use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements. (Source: Journal of Public Health Management and Practice)
Source: Journal of Public Health Management and Practice - July 28, 2015 Category: Health Management Tags: Original Articles Source Type: research

Next-generation sequencing to guide cancer therapy
Abstract As a result of multiple technological and practical advances, high-throughput sequencing, known more commonly as “next-generation” sequencing (NGS), can now be incorporated into standard clinical practice. Whereas early protocols relied on samples that were harvested outside of typical clinical pathology workflows, standard formalin-fixed, paraffin-embedded specimens can more regularly be used as starting materials for NGS. Furthermore, protocols for the analysis and interpretation of NGS data, as well as knowledge bases, are being amassed, allowing clinicians to act more easily on genomic informatio...
Source: Genome Medicine - July 28, 2015 Category: Genetics & Stem Cells Source Type: research

A systematic review of the use of expandable cages in the cervical spine
The objective of this study was to perform a systematic review on the use of expandable cages in the treatment of cervical spine pathology with a focus on fusion rates, deformity correction, complications, and indications. A comprehensive Medline search was performed, and 24 applicable articles were identified and included in this review. The advantages of expandable cages include greater ease of implantation with less risk of damage to the end plate, less intraoperative manipulation of the device, and potentially greater control over lordosis. They may be particularly advantageous in cases with poor bone quality, such as ...
Source: Neurosurgical Review - July 28, 2015 Category: Neurosurgery Source Type: research

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles
To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry and publication data for randomized clinical trials (RCT) after introduction of Food and Drug Administration Amendment Act (FDAAA). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - July 28, 2015 Category: Epidemiology Authors: Shelly Pranić, Ana Marušić Source Type: research

Permanent skin discoloration possible with Daytrana patch
The Food and Drug Administration has warned that the Daytrana patch (methylphenidate transdermal system) may cause permanent skin color changes. The Daytrana patch, for attention‐deficit hyperactivity disorder, now has a new warning on the label to describe chemical leukoderma. This is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotio...
Source: The Brown University Child and Adolescent Psychopharmacology Update - July 28, 2015 Category: Psychiatry Tags: From the FDA Source Type: research

Plant alkaloids as drug leads for Alzheimer’s disease
Publication date: Available online 26 July 2015 Source:Neurochemistry International Author(s): Yu Pong Ng, Terry Cho, Tsun Or, Nancy Y. Ip Alzheimer’s disease (AD) is a neurodegenerative illness associated with dementia and is most prevalent among the elderly population. Current medications can only treat symptoms. Alkaloids are structurally diverse and have been an important source of therapeutics for various brain disorders. Two US Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitors for AD, galantamine and rivastigmine, are in fact alkaloids. In addition, clinical trials of four other exte...
Source: Neurochemistry International - July 27, 2015 Category: Neuroscience Source Type: research

Family input vital to rare diseases drug development process [FDA UPDATE]
(Source: AAP News)
Source: AAP News - July 27, 2015 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, Rare Diseases Program Tags: FDA Update, Pharmacology Source Type: research

Informed Consent and Research on Higher-Risk Medications
The Belmont Report formally established ethical principles and guidelines in 1979 for the protection of human research subjects in the United States. Summarizing discussions among the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research from an initial 4-day meeting at the Smithsonian Institution’s Belmont Conference Center, as well as several years of subsequent deliberations, 3 core principles were identified in the Belmont Report: respect for persons, beneficence, and justice. While these principles frequently come into play in clinical research, the Belmont Report suggests th...
Source: JAMA Internal Medicine - July 27, 2015 Category: Internal Medicine Source Type: research

Improving Manufacturer Reporting of Adverse Events to the FDA
Our awareness of the potential adverse effects (AEs) of newly approved drugs and devices is limited. Premarket trials are often small and of limited duration, and the patients in clinical trials are healthier than unselected patients in routine clinical practice. Thus, the public and physicians rely on the US Food and Drug Administration (FDA) Adverse Event Reporting System to inform us of unknown or unsuspected risks associated with use of drugs and devices. (Source: JAMA Internal Medicine)
Source: JAMA Internal Medicine - July 27, 2015 Category: Internal Medicine Source Type: research

Delay of Manufacturer Disclosure of Adverse Events to the FDA
This study investigates patient and event characteristics associated with manufacturers’ delayed submission of expedited adverse event reports to the US Food and Drug Administration. (Source: JAMA Internal Medicine)
Source: JAMA Internal Medicine - July 27, 2015 Category: Internal Medicine Source Type: research

The Pharmacology and Clinical Use of the Antidepressants Vilazodone, Levomilnacipran, and Vortioxetine for Depression in the Elderly
This article will examine the potential role in the elderly of the three latest antidepressants approved by the US Food and Drug Administration: vilazodone (January 2011), levomilnacipran (July 2013), and vortioxetine (September 2013). Thus far, vortioxetine was shown to be efficacious and tolerable in the elderly. Sub-group analyses involving vilazodone and levomilnacipran appear to show a similar efficacy in older compared with younger adults, although these are limited by small sample sizes. Issues related to pharmacodynamics, safety, tolerability, and the unique features associated with these drugs are further discusse...
Source: Current Geriatrics Reports - July 25, 2015 Category: Geriatrics Source Type: research

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research
This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty. (Source: Journal of Vascular and Interventional Radiology)
Source: Journal of Vascular and Interventional Radiology - July 24, 2015 Category: Radiology Source Type: research

Evaluating your obligations for employee training according to the Food Safety Modernization Act
Publication date: February 2016 Source:Food Control, Volume 60 Author(s): Samantha Shinbaum, Philip G. Crandall, Corliss A. O'Bryan The signing of the Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA) into law in 2011 elevated the FDA into a significantly higher, international operational role to implement a new, prevention-oriented, systems-wide approaches to food safety for the entire spectrum of non-meat foods. After decades of failed regulatory attempts to “inspect food safety into” the nation's food supply, FSMA puts the responsibility for food safety where the liability resides, with ...
Source: Food Control - July 24, 2015 Category: Food Science Source Type: research

Identification and quantification of 1,3-dimethylbutylamine (DMBA) from Camellia sinensis tea leaves and dietary supplements
Publication date: 10 November 2015 Source:Journal of Pharmaceutical and Biomedical Analysis, Volume 115 Author(s): Bharathi Avula, Mei Wang, Satyanarayanaraju Sagi, Pieter A. Cohen, Yan-Hong Wang, Pradeep Lasonkar, Amar Chittiboyina, Wei Feng, Ikhlas A. Khan 1,3-dimethylbutylamine (DMBA), is a CNS stimulant, which has recently been identified in multiple dietary supplements and sometimes labeled as a natural constituent of Pouchung tea. DMBA is an homologue of 1,3-dimethylamylamine (DMAA) which the US Food and Drug Administration has attempted to remove from all dietary supplements after DMAA consumption was lin...
Source: Journal of Pharmaceutical and Biomedical Analysis - July 24, 2015 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic Aspects of Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitors
Abstract Scientists have identified the impact of angiogenesis on tumor growth and survival. Among other efficient drugs, several small-molecule tyrosine kinase inhibitors (TKIs) targeting the vascular endothelial growth factor receptor (VEGFR) have been developed and have already been integrated into the treatment of various advanced malignancies. This review provides a compilation of current knowledge on the pharmacokinetic aspects of all VEGFR–TKIs already approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and of those still under investigation. Additional informatio...
Source: Clinical Pharmacokinetics - July 23, 2015 Category: Drugs & Pharmacology Source Type: research

Monitoring of suicide risk throughout the course of treatment with antidepressants for depression is required, but vigilance is required for those on some particular antidepressant agents
ABSTRACT FROM: Coupland C, Hill T, Morriss R, et al. Antidepressant use and risk of suicide and attempted suicide or self harm in people aged 20 to 64: cohort study using a primary care database. BMJ 2015;350:h517. What is already known on this topic Evidence of an increase in suicidal behaviours in children and adolescents prescribed antidepressants resulted in a Food and Drug Administration (FDA) ‘black box’ warning in 2004 for this age group. This was extended to young adults up to the age of 24 years in 2007. A link with suicide has not been clearly demonstrated for any age group, nor have differences ...
Source: Evidence-Based Mental Health - July 23, 2015 Category: Psychiatry & Psychology Authors: Hetrick, S. Tags: Epidemiologic studies, General practice / family medicine, Suicide (psychiatry), Epidemiology Causes and risk factors Source Type: research

FDA reverses debarment of one of its ex-chemists
US Food and Drug Administration lifts ban on chemist who worked at the agency, more than 20 years after he was sentenced for taking bribes (Source: Chemistry World | Latest News)
Source: Chemistry World | Latest News - July 23, 2015 Category: Chemistry Authors: Rebecca Trager Source Type: research

Use of data mining at the food and drug administration
This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA).Target audience We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities.Scope Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA. (Source: Journal of the American Medical In...
Source: Journal of the American Medical Informatics Association - July 23, 2015 Category: Information Technology Authors: Duggirala, H. J., Tonning, J. M., Smith, E., Bright, R. A., Baker, J. D., Ball, R., Bell, C., Bright-Ponte, S. J., Botsis, T., Bouri, K., Boyer, M., Burkhart, K., Steven Condrey, G., Chen, J. J., Chirtel, S., Filice, R. W., Francis, H., Jiang, H., Levine, Tags: Review Source Type: research

Generic lamotrigine versus brand‐name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard
Summary ObjectiveTo test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand‐name drug pharmacokinetic (PK) performance in “generic‐brittle” patients with epilepsy under clinical use conditions. MethodsThis randomized, double‐blind, multiple‐dose, steady‐state, fully replicated bioequivalence study compared generic lamotrigine to brand‐name Lamictal in “generic‐brittle” patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood s...
Source: Epilepsia - July 23, 2015 Category: Neurology Authors: Tricia Y. Ting, Wenlei Jiang, Robert Lionberger, Jessica Wong, Jace W. Jones, Maureen A. Kane, Allan Krumholz, Robert Temple, James E. Polli Tags: Full‐Length Original Research Source Type: research

A comprehensive review of lenalidomide therapy for B-cell non-Hodgkin lymphoma
Lenalidomide is an oral non-chemotherapy immunomodulator with direct and indirect effects on non-Hodgkin lymphoma (NHL) cells and with single-agent activity in relapsed/refractory aggressive and indolent B-cell NHL, including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma, and follicular lymphoma. Based on the pivotal phase II MCL-001 trial of lenalidomide in heavily pretreated patients with relapsed/refractory MCL, lenalidomide was approved by the US Food and Drug Administration for the treatment of relapsed/refractory MCL after failure of two prior therapies, one of which includes bortezomib, at a recommended ...
Source: Annals of Oncology - July 22, 2015 Category: Cancer & Oncology Authors: Witzig, T. E., Nowakowski, G. S., Habermann, T. M., Goy, A., Hernandez-Ilizaliturri, F. J., Chiappella, A., Vitolo, U., Fowler, N., Czuczman, M. S. Tags: reviews Source Type: research

Worsening renal function in patients with baseline renal impairment treated with intravenous voriconazole: A systematic review
Invasive fungal infections pose a significant threat to burn victims, immunocompromised patients including those with neutropenia, human immunodeficiency virus (HIV) infection or treated with immunosuppressive drugs, and even patients who are immunocompromised due to the widespread use of broad-spectrum antimicrobial therapies [1]. Voriconazole, a second-generation triazole antifungal agent approved by the US Food and Drug Administration (FDA) in 2002, is active against many invasive fungi belonging to genera such as Aspergillus, Candida and Cryptococcus and has been proven to be a very effective treatment for infections c...
Source: International Journal of Antimicrobial Agents - July 22, 2015 Category: Drugs & Pharmacology Authors: R. Brigg Turner, Jay Martello, Ashim Malhotra Tags: Review Source Type: research

Synthetic ACTH is not superior to prednisolone for infantile spasms – Randomized clinical trials and tribulations
There are only three therapies with greater than Class IV evidence to support their use for the treatment of infantile spasms – adrencorticotropic hormone (ACTH), vigabatrin and oral corticosteroids.1 In the United States, only natural ACTH and vigabatrin are approved by the Food and Drug Administration (FDA) for infantile spasms. However, for decades oral corticosteroids have been used ‘off label’ for the treatment of infantile spasms. In contrast to ACTH and vigabatrin, oral corticosteroids are far less expensive (less than $40 for a one month course), easy to administer, and readily available in most parts of the ...
Source: Pediatric Neurology - July 22, 2015 Category: Neurology Authors: John R. Mytinger Tags: Editorial/Invited Commentary/Overview/Tribute Source Type: research

Small-molecule kinase inhibitors: an analysis of FDA-approved drugs.
Abstract Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and therapeutic indications of these approved inhibitors. Our analysis showed that >30% of approved SMKIs have a molecule weight (MW) exceeding 500 and all have a total ring count of between three and five. The assumption that type II inhibitors tend to be more selective than type I inhibitors has been proved to be unre...
Source: Drug Discovery Today - July 22, 2015 Category: Drugs & Pharmacology Authors: Wu P, Nielsen TE, Clausen MH Tags: Drug Discov Today Source Type: research

Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis.
Abstract PURPOSE: The use of intravenous golimumab (GLM-IV), in combination with methotrexate, was approved by the US Food and Drug Administration in July 2013 for the treatment of moderate to severe, active rheumatoid arthritis (RA). GLM-IV is available in 50-mg vials, and the prescribing information specifies a dosing regimen of 2 mg/kg at 0 and 4 weeks and then every 8 weeks thereafter. The purpose of this study was to examine the patterns of prescribing and administration of GLM-IV, including the demographic, clinical, and utilization characteristics of patients with RA newly treated with GLM-IV. METHODS: R...
Source: Clinical Therapeutics - July 22, 2015 Category: Drugs & Pharmacology Authors: Brady BL, Tkacz JP, Lofland J, Meyer R, Bolge SC Tags: Clin Ther Source Type: research

Development and Integration of Antibody–Drug Conjugate in Non-Hodgkin Lymphoma
Abstract Rituximab, a monoclonal antibody (MAb) against CD20, was the first MAb approved by the US Food and Drug Administration (FDA) for treatment of B cell non-Hodgkin lymphoma (B-NHL). Conjugating toxins to MAb was a technical challenge; however, with improvements in linker technology, immunoconjugates were constructed and revolutionized cancer treatment. Gemtuzumab ozogamicin was the first antibody drug conjugate (ADC) approved by the FDA. Because of the success of brentuximab vedotin and ado-trastuzumab emtansine in treating Hodgkin lymphoma (HL) and HER2-positive breast cancer, respectively, newer ADCs are ...
Source: Current Oncology Reports - July 21, 2015 Category: Cancer & Oncology Source Type: research

The Safety of Prescription Drugs
Drug safety challenges have bedeviled the US Food and Drug Administration (FDA) for many years, and for good reason. The phased approach to drug development is primarily geared to establishing evidence of efficacy. Hundreds, perhaps thousands, of patients are exposed to an investigational drug in clinical trials. However, it may not be until after approval, when the medication is used by as many as hundreds of thousands of patients, that rare but serious adverse events appear or there is sufficient statistical power to determine whether the drug increases rates of more common potential adverse outcomes, such as cardiovascu...
Source: JAMA - July 21, 2015 Category: Journals (General) Source Type: research

Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments
Publication date: 15 August 2015 Source:International Journal of Pharmaceutics, Volume 492, Issues 1–2 Author(s): Ghada ElAgouri, Fatema ElAmrawy, Ahmed ElYazbi, Ahmed Eshra, Mohamed I. Nounou The global market is invaded by male enhancement nutraceuticals claimed to be of natural origin sold with a major therapeutic claim. Most of these products have been reported by international systems like the Food and Drug Administration (FDA). We hypothesize that these products could represent a major threat to the health of the consumers. In this paper, pharmaceutical evaluation of some of these nutraceutical products sold...
Source: International Journal of Pharmaceutics - July 20, 2015 Category: Drugs & Pharmacology Source Type: research

Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research
Measuring lupus disease activity accurately remains a challenging and demanding task given the complex multi-system nature of lupus, an illness known for its variability between patients and within the same patient over time. Many have attempted to define what disease activity means and how it should be measured, and several instruments were devised for a standardized assessment of disease activity and outcome domains in clinical research. Several of these measuring tools have been able to detect clinical improvement and have demonstrated adequate reliability, validity, and sensitivity to change in observational studies, a...
Source: Arthritis Research and Therapy - July 20, 2015 Category: Rheumatology Authors: Jamal MikdashiOla Nived Source Type: research

Generics: Are all immunosuppression agents created equally?
The Affordable Care Act initiated innumerable cost-containment measures, including promoting generic conversion from brand medications and directing the Food and Drug Administration to decrease requirements for generic approvals. Despite this mandate, few data existed on generic conversion of immunosuppressant medications with narrow therapeutic troughs. (Source: Surgery)
Source: Surgery - July 20, 2015 Category: Surgery Authors: Adam Hauch, Mira John, Alison Smith, Isabelle Dortonne, Ushma Patel, Emad Kandil, Mary Killackey, Anil Paramesh, Belinda Lee, Rubin Zhang, Joseph F. Buell Tags: Clinical Research Source Type: research

Reply
Peyronie's Disease (PD) is a fascinating urologic condition. There continues to be an evolution in the basic, clinical, surgical, and psychosexual aspects of this relatively common condition. It is worthy to note that the Food and Drug Administration (FDA) mandated the Peyronie's Disease Questionnaire (PDQ), which in collaboration with expert advisors and the FDA Study Endpoints and Development Group, took more than 8 years to create.1 The PDQ (available at http://www.auxilium.com) is a 15-item, multidimensional questionnaire that quantifies the psychosexual symptom changes of men with PD at baseline, and over a defined t...
Source: Urology - July 18, 2015 Category: Urology & Nephrology Authors: Wayne J.G. Hellstrom Tags: Male Sexual Dysfunction Source Type: research

Standardizing Data Exchange for Clinical Research Protocols and Case Report Forms: An Assessment of the Suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)
Publication date: Available online 15 July 2015 Source:Journal of Biomedical Informatics Author(s): Vojtech Huser, Chandan Sastry, Matthew Breymaier, Asma Idriss, James J. Cimino Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regu...
Source: Journal of Biomedical Informatics - July 17, 2015 Category: Information Technology Source Type: research

Transcatheter pulmonary valve implantation: A cross-sectional US experience
More than a decade ago Bonhoeffer et al. [1] demonstrated implantation of transcatheter pulmonary valve (TPV) in a RVOT (Right Ventricular Outflow Tract) conduit with a device comprising a balloon-expandable stent with mounted bovine jugular venous valve. US food and Drug Administration (FDA) approved modified version of the original device, the Melody valve (Medtronic Inc, Minneapolis, Minnesota) in 2010 after the original Investigational Device Exemption (IDE #G050186) trial [2]. The results of this study and its continuing study done by McElhinney et al. (Source: International Journal of Cardiology)
Source: International Journal of Cardiology - July 17, 2015 Category: Cardiology Authors: Achint Patel, Aashay Patel, Parth Bhatt, Chirag Savani, Badal Thakkar, Rajesh Sonani, Nileshkumar J. Patel, Shilpkumar Arora, Sidakpal Panaich, Vikas Singh, Samir Patel, Sadip Pant, Mohammad M. Ansari, Abhishek Deshmukh, Nilay Patel, Abhishek Dave, Cindy Tags: Letter to the Editor Source Type: research

Intrathecal 2-hydroxypropyl-beta-cyclodextrin in a single patient with Niemann–Pick C1
Publication date: Available online 15 July 2015 Source:Molecular Genetics and Metabolism Author(s): Timothy J. Maarup, Agnes H. Chen, Forbes D. Porter, Nicole Y. Farhat, Daniel S. Ory, Rohini Sidhu, Xuntian Jiang, Patricia I. Dickson Niemann–Pick C, type 1 (NPC1) is a progressive autosomal recessive neurologic disease caused by defective intracellular cholesterol and lipid trafficking. There are currently no United States Food and Drug Administration approved treatments for NPC1. We undertook a study evaluating the safety, efficacy, and biomarker response of intrathecal 2-hydroxypropyl-β-cyclodextrin (HP-β-CD...
Source: Molecular Genetics and Metabolism - July 16, 2015 Category: Genetics & Stem Cells Source Type: research

US import ban imposed on Indian pharma firm
Concerns over manufacturing processes at Emcure facility prompts Food and Drug Administration to block drug shipments (Source: Chemistry World | Latest News)
Source: Chemistry World | Latest News - July 16, 2015 Category: Chemistry Authors: Rebecca Trager Source Type: research

Production of Human Dental Pulp Cells with a Medicinal Manufacturing Approach
Human dental pulp cells (HDPCs) are generally isolated and cultured with xenogeneic products and in stress conditions that may alter their biological features. However, guidelines from the American Food and Drug Administration and the European Medicines Agency currently recommend the use of protocols compliant with medicinal manufacturing. Our aim was to design an ex vivo procedure to produce large amounts of HDPCs for dentin/pulp and bone engineering according to these international recommendations. (Source: Journal of Endodontics)
Source: Journal of Endodontics - July 16, 2015 Category: Dentistry Authors: Maxime Ducret, Hugo Fabre, Jean-Christophe Farges, Olivier Degoul, Gianluigi Atzeni, Colin McGuckin, Nico Forraz, Frédéric Mallein-Gerin, Emeline Perrier-Groult Tags: Basic Research Source Type: research

Clinical Management of Ebola Virus Disease Patients
Opinion statement The mainstay of Ebola virus disease (EVD) management is supportive care of complications, and types of interventions used may range from basic oral rehydration and symptom management to critical care with advanced organ support, depending on the resources of the treatment facility. Adequate fluid resuscitation, management of electrolyte and acid-base disturbances, treatment of symptoms, and antimicrobial therapy for possible co-infections are key. There are no specific Food and Drug Administration (FDA)-approved therapies for treatment of EVD. Several investigational therapies have shown promise ...
Source: Current Treatment Options in Infectious Diseases - July 16, 2015 Category: Infectious Diseases Source Type: research

Atrial Septal Defect Device Closure in the Pediatric Population: A Current Review
Abstract Atrial septal defects are the most common congenital cardiac defects. The natural history of an uncorrected atrial septal defect causes a shortened life expectancy due to right ventricular volume overload and associated congestive heart failure, atrial arrhythmias, and/or pulmonary vascular disease. Surgical closure of the atrial septal defect is a procedure with a long-standing history, and the maturing field of percutaneous closure of atrial septal defects by device implantation has established itself to be a feasible, minimally invasive, and safe procedure. Inherent limitations in device designs ha...
Source: Current Pediatrics Reports - July 16, 2015 Category: Pediatrics Source Type: research

Reorienting the immune system in the treatment of cancer by using anti-PD-1 and anti-PD-L1 antibodies.
Abstract Physiologically, the programmed death 1 (PD-1) pathway is involved in limiting the killing of bystander cells during an infection and controlling autoimmunity. However, cancers exploit this system to avoid immune killing, and PD-1 ligand 1 and 2 (PD-L1 and PD-L2) expression on tumor cells, as well as PD-1 expression on tumor-infiltrating lymphocytes, have shown to be negative prognostic factors. Promising clinical results have been obtained by PD-1 pathway blockade in a range of cancers while still maintaining a manageable toxicity profile, and two anti-PD-1 antibodies are now approved by the US Food and D...
Source: Drug Discovery Today - July 16, 2015 Category: Drugs & Pharmacology Authors: Borch TH, Donia M, Andersen MH, Svane IM Tags: Drug Discov Today Source Type: research

Citrobacter braakii: A Major Cause of False‐Positive Results on MacConkey and Levine's Eosin Methylene Blue Selective Agars Used for the Isolation of Escherichia Coli from Fresh Vegetable Samples
In this study, we investigated the efficiency of conventional E. coli selective medium, MacConkey (MAC) agar, for the screening of fresh vegetable samples and evaluated the discrimination ability of Levine's eosin methylene blue (L‐EMB) agar for E. coli‐like colonies obtained from MAC agar. A total of 120 samples of lettuces (n = 60) and radish sprouts (n = 60) were analyzed. Among 17 (14.2%) MAC agar plates containing putative E. coli colonies, only one plate was confirmed E. coli‐positive (positive predictive value = 5.9%). All 16 false‐positive isolates were identified as Citrobacter braakii ...
Source: Journal of Food Safety - July 15, 2015 Category: Food Science Authors: Hong‐Seok Kim, Young‐Ji Kim, Jung‐Whan Chon, Dong‐Hyeon Kim, Kwang‐Yeop Kim, Kun‐Ho Seo Tags: Original Article Source Type: research

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research
This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty. (Source: Journal of Vascular and Interventional Radiology : JVIR)
Source: Journal of Vascular and Interventional Radiology : JVIR - July 15, 2015 Category: Radiology Authors: Ashley Adamovich, Susie Park, Gary P. Siskin, Meridith J. Englander, Kenneth D. Mandato, Allen Herr, Lawrence J. Keating Tags: Review Article Source Type: research

Glycoprotein IIb/IIIa inhibitors: The resurgence of tirofiban.
Abstract Glycoprotein (GP) IIb/IIIa inhibitors block platelet aggregation, reducing thrombotic events in acute coronary syndrome. They are most often utilized in patients who likely have an intracoronary thrombus. Tirofiban, eptifibatide, and abciximab are the three GP IIb/IIIa inhibitors approved for use in the United States. Each agent has unique pharmacological properties. They all have a rapid onset and are most often utilized in conjunction with heparin. Tirofiban, in particular, fell out of favor due to inferior dosing with its original Food and Drug Administration (FDA) approved indication, but has re-emerge...
Source: Vascular Pharmacology - July 15, 2015 Category: Drugs & Pharmacology Authors: King S, Short M, Harmon C Tags: Vascul Pharmacol Source Type: research