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[In Depth] Doubts dispelled about HIV prevention
Nearly 5 years ago, a large study showed that taking an anti-HIV pill each day can protect people at high risk of becoming infected. But despite several confirmatory trials and approval by the U.S. Food and Drug Administration, so-called pre-exposure prophylaxis, or PrEP, hasn't been used much. New studies reported last week at a major HIV/AIDS conference in Seattle, Washington, promise to make PrEP far more popular. The studies once again show that PrEP offers solid protection for men who have sex with men and heterosexuals—if it is used as prescribed. But they go further and show novel ways to take advantage of PrEP, i...
Source: Science: Current Issue - March 6, 2015 Category: Science Authors: Jon Cohen Tags: Infectious Diseases Source Type: research

[Heart Failure] Taking antidepressants to heart
Drug repurposing—using drugs already approved by the Food and Drug Administration for new diseases—can save money and time. The antidepressant paroxetine, a selective serotonin reu – [Read More] (Source: This Week in Science)
Source: This Week in Science - March 6, 2015 Category: Science Authors: Angela Colmone Tags: Heart Failure Source Type: research

Sodium-glucose cotransporter 2 inhibitors: the new option for diabetes mellitus management.
This article reviews the new sodium-glucose cotransporter 2 inhibitors canagliflozin and dapagliflozin, including their benefits, adverse effects, and potential place in therapy. Upon review, the use of these medications has led to an A1c reduction between -0.37% and -1.16%. These medications also have been shown to reduce A1c when used with insulin. Some adverse effects were noted when using canagliflozin and dapagliflozin, with the most frequent being urinary tract infections and genital mycotic infections. We review the sodium-glucose cotransporter 2 inhibitors approved by the US Food and Drug Administration and their p...
Source: Southern Medical Journal - March 4, 2015 Category: Journals (General) Tags: South Med J Source Type: research

Promotion of “Low T” and citation bias in testosterone studies
The “Low T” marketing campaign playing on older men's concerns about flagging masculinity has driven a dramatic increase in testosterone prescription in the last few years, particularly in North America. However, sales of testosterone are now falling again [1], as regulators, particularly Health Canada [2], have drawn attention to the cardiovascular risk of testosterone supplementation. Health Canada, the Food and Drug Administration and the European Medicines Agency have all advised that testosterone prescription should be restricted [2–4], consistent with the lack of established benefit and the potential risk poten...
Source: International Journal of Cardiology - March 4, 2015 Category: Cardiology Authors: Jie Zhao, C. Mary Schooling Tags: Letter to the Editor Source Type: research

Biomarker development in the context of urologic cancers
This article discusses development and application of these biomarkers in the context of urologic cancers—specifically in cancers of the prostate and urinary bladder. (Source: Urologic Oncology: Seminars and Original Investigations)
Source: Urologic Oncology: Seminars and Original Investigations - March 4, 2015 Category: Urology & Nephrology Authors: Gary J. Kelloff, Caroline C. Sigman, Howard I. Scher Tags: Seminars article Source Type: research

Bevacizumab in combination with anticancer drugs for previously treated advanced non-small cell lung cancer
Abstract Non-small cell lung cancer (NSCLC) accounts for about 85 % of all lung cancer cases. Patients with NSCLC often have an advanced disease at the time of diagnosis, with a 1-year survival rate about 10–15 % under the best support treatment. As therapeutic methods for lung cancer developed rapidly in recent years, the prognosis of stage IIIB or IV NSCLC also improve to a large extend. Bevacizumab is a monoclonal antibody against VEGFR which inhibits abnormal vascular growth in malignant tumors. In October 2006, bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for first-line use in a...
Source: Tumor Biology - March 3, 2015 Category: Cancer & Oncology Source Type: research

Process analytical technology for continuous manufacturing of solid-dosage forms
Publication date: Available online 26 February 2015 Source:TrAC Trends in Analytical Chemistry Author(s): Margot Fonteyne , Jurgen Vercruysse , Fien De Leersnyder , Bernd Van Snick , Chris Vervaet , Jean Paul Remon , Thomas De Beer Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the advantages of continuous processing, so the critical quality attributes of continuously produced pharmac...
Source: TrAC Trends in Analytical Chemistry - March 3, 2015 Category: Chemistry Source Type: research

Application of RP–HPLC method in dissolution testing and statistical evaluation by NASSAM for simultaneous estimation of tertiary combined dosages forms
Publication date: Available online 26 November 2014 Source:Journal of Pharmaceutical Analysis Author(s): Yogesh Upadhyay , Nitin Sharma , G.S. Sarma , Ravindra K. Rawal A dissolution method with robust high performance liquid chromatographic (HPLC) analysis for immediate release tablet formulation was developed and validated to meet the requirement as per International Conference on Harmonization (ICH) and United States Food and Drug Administration (USFDA) guidelines. The method involved the use of Agilent ZORBAX Eclipse XDB C18 column and temperature was maintained at 30°C. After optimization the mobile phase was selec...
Source: Journal of Pharmaceutical Analysis - March 3, 2015 Category: Drugs & Pharmacology Source Type: research

Medicaid Prior Authorization Policies for Pediatric Use of Antipsychotic Medications
Over the past 2 decades, antipsychotic prescribing to youth, almost exclusively comprising atypical antipsychotic medications, was estimated to have increased from 0.16% in 1993-1998 to 1.07% in 2005-2009 in office-based physician visits. Antipsychotic use is also 5-fold greater in Medicaid-insured youth than in privately insured youth, and occurs mostly for youth with clinician-reported externalizing behavior disorders rather than indications approved by the US Food and Drug Administration (FDA) and indications that are evidence-supported without FDA-approved labeling (eg, psychotic disorders, bipolar disorder, autism-rel...
Source: JAMA - March 3, 2015 Category: Journals (General) Source Type: research

Red Yeast Rice for the Treatment of Dyslipidemia
Abstract Red yeast rice (RYR) is a Chinese herbal supplement produced by fermenting white rice with the yeast, Monascus purpureus. The Chinese have used RYR to flavor, color, and preserve foods and as a traditional medicine for many years. In the USA, RYR has been used as an alternative to statin therapy in treating patients with mild to moderate hypercholesterolemia. RYR contains a variety of monacolins, which inhibit hydroxymethylglutaryl-coenzyme A (HMG CoA) reductase, the rate-limiting step in cholesterol synthesis. Consumption of RYR has increased recently especially among patients who might be intolerant to...
Source: Current Atherosclerosis Reports - March 2, 2015 Category: Cardiology Source Type: research

Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease Consensus Definitions From Peripheral Academic Research Consortium (PARC)
The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, a...
Source: Journal of the American College of Cardiology - March 2, 2015 Category: Cardiology Source Type: research

Mandatory Disclaimers On Dietary Supplements Do Not Reliably Communicate The Intended Issues [Patient Engagement]
Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have recently been found unconstitutional under the First Amendment, which has been interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform consum...
Source: Health Affairs - March 2, 2015 Category: Global & Universal Authors: Kesselheim, A. S., Connolly, J., Rogers, J., Avorn, J. Tags: Legal/Regulatory Issues, Pharmaceuticals, Public Health, Quality Of Care, Consumer Issues Patient Engagement Source Type: research

Ondansetron and the Risk of QTc Prolongation
Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, such as ondansetron, granisetron, dolasetron, and palonosetron, are frequently used to manage emesis associated with chemotherapy or surgical procedures. Ondansetron, the first 5-HT3 antagonist, was approved by the Unites States Food and Drug Administration (FDA) in 1991 for the prevention of chemotherapy-induced nausea and vomiting (CINV), and subsequently gained approval for the prevention of radiotherapy-induced nausea and vomiting (NV), postoperative NV, and for use in pediatrics. (Source: The Journal for Nurse Practitioners)
Source: The Journal for Nurse Practitioners - March 2, 2015 Category: Nursing Authors: Sarah Kator, Sara S. Kim Tags: Prescription Pad Source Type: research

Michaelis–Menten elimination kinetics of etanercept, rheumatoid arthritis biologics, after intravenous and subcutaneous administration in rats
Abstract Etanercept was approved by the Food and Drug Administration (FDA) in 2010 as a biologic agent for the treatment of rheumatoid arthritis (RA). The aim of the study was to investigate the pharmacokinetic properties of etanercept after intravenous and subcutaneous injection in rats. The plasma concentration of etanercept was determined using an enzyme-linked immunosorbent assay (ELISA). Intravenous and subcutaneous administration of 2 mg/kg of etanercept to rats showed that etanercept was slowly absorbed (time to reach the peak drug concentration [T max] = 1.60 days, bioavailability [F] = 47....
Source: European Journal of Drug Metabolism and Pharmacokinetics - March 1, 2015 Category: Drugs & Pharmacology Source Type: research

The Discover Artificial Disc Replacement versus Fusion in Cervical Radiculopathy - A Randomized Controlled Outcome Trial with Two Years follow-up
This study is not, in contrast to most previous studies, an investigational device exemption-study required by the Food and Drug Administration for approval to market the product in the U.S. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc, used in this study. (Source: The Spine Journal)
Source: The Spine Journal - February 28, 2015 Category: Orthopaedics Authors: M. Skeppholm, L. Lindgren, T. Henriques, L. Vavruch, H. Löfgren, C. Olerud Tags: Clinical studies Source Type: research

The FDA Revises Pregnancy Risk Information
* The Food and Drug Administration has finalized revisions to the format and content of pregnancy and lactation information in the labeling of prescription drugs and biological products. * The pregnancy categories A, B, C, D, and X will be eliminated. In their place will be “Risk Summary” narratives concerning both pregnancy and lactation. There will also be a summary of information on pregnancy testing, contraception, and infertility under a subheading “Females and Males of Reproductive Potential.” (Source: AJN)
Source: AJN - February 27, 2015 Category: Nursing Tags: Drug Watch Source Type: research

[Correspondence] Alemtuzumab induction therapy in kidney transplantation
The 3C Study Collaborative Group report a reduction of biopsy-proven acute rejection (BPAR) from 16% with basiliximab to 7% with alemtuzumab in a randomised trial of 852 renal transplant recipients.1 Despite its rather high rate and standardised detection, BPAR nowadays should no longer guide treatment decisions. Early BPAR without effect on graft function is well known to have no effect on long-term outcomes.2 Hence, for trials of renal transplantation, both the European Medicines Agency and US Food and Drug Administration have suggested use of combined primary endpoints that include patient and graft survival, and graft ...
Source: LANCET - February 27, 2015 Category: Journals (General) Authors: Andrea Berghofen, Thomas Singer, Bernd Krüger, Bernhard K Krämer, Urs Benck Tags: Correspondence Source Type: research

[Perspectives] Robert Califf: leading cardiologist is new FDA Deputy Commissioner
As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA's overall responsibilities have grown exponentially as a result of five new major legislative mandates, more complex regulatory science, and an increase in health-care data, despite a tightening federal budget. Califf will oversee an annual budget of about US$2·3 billion and about half the agency's 16 000 employees working at the FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices ...
Source: LANCET - February 27, 2015 Category: Journals (General) Authors: Susan Jaffe Tags: Perspectives Source Type: research

[World Report] US FDA: the Margaret Hamburg years
US Food and Drug Administration commisioner Margaret Hamburg is stepping down after nearly 6 years in office. The Lancet's Washington correspondent Susan Jaffe reports on her achievements. (Source: LANCET)
Source: LANCET - February 27, 2015 Category: Journals (General) Authors: Susan Jaffe Tags: World Report Source Type: research

PCSK9 inhibition to reduce cardiovascular disease risk: recent findings from the biology of PCSK9
We describe mechanisms that can explain the effect on lipoprotein(a), predict a potential effect on postprandial triglyderides, and suggest a new category of patients for anti-PCSK9 therapy. (Source: Current Opinion in Endocrinology, Diabetes and Obesity)
Source: Current Opinion in Endocrinology, Diabetes and Obesity - February 27, 2015 Category: Endocrinology Tags: LIPIDS: Edited by Annabelle Rodriguez Source Type: research

Revised Device Labeling for the Cepheid Xpert MTB/RIF Assay for Detecting Mycobacterium tuberculosis.
Abstract The Food and Drug Administration (FDA) has cleared the Xpert MTB/RIF Assay (Cepheid; Sunnyvale, California) with an expanded intended use that includes testing of either one or two sputum specimens as an alternative to examination of serial acid-fast stained sputum smears to aid in the decision of whether continued airborne infection isolation (AII) is warranted for patients with suspected pulmonary tuberculosis. This change reflects the outcome of a recent multicenter international study demonstrating that negative Xpert MTB/RIF Assay results from either one or two sputum specimens are highly predictive o...
Source: MMWR Morb Mortal Wkl... - February 27, 2015 Category: Epidemiology Authors: Division of Microbiology Devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products
Discussion focused on whether PK would be the most sensitive marker of bioequivalence. Furthermore, there was much discussion about the FDA draft guidance for generic fluticasone propionate/salmeterol. The opinion was expressed that the study design is not capable of detecting a non-equivalent product and would require an unfeasibly large sample size. (Source: The AAPS Journal)
Source: The AAPS Journal - February 26, 2015 Category: Drugs & Pharmacology Source Type: research

Janus kinase inhibition by ruxolitinib extends dasatinib- and dexamethasone-induced remissions in a mouse model of Ph+ ALL
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) is initiated and driven by the oncogenic fusion protein BCR-ABL, a constitutively active tyrosine kinase. Despite major advances in the treatment of this highly aggressive disease with potent inhibitors of the BCR-ABL kinase such as dasatinib, patients in remission frequently relapse due to persistent minimal residual disease possibly supported, at least in part, by salutary cytokine-driven signaling within the hematopoietic microenvironment. Using a mouse model of Ph+ ALL that accurately mimics the genetics, clinical behavior, and therapeutic response...
Source: Blood - February 26, 2015 Category: Hematology Authors: Appelmann, I., Rillahan, C. D., de Stanchina, E., Carbonetti, G., Chen, C., Lowe, S. W., Sherr, C. J. Tags: Lymphoid Neoplasia Source Type: research

Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent
Abstract In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)‐regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this ar...
Source: Academic Emergency Medicine - February 25, 2015 Category: Emergency Medicine Authors: Michelle H. Biros, Neal W. Dickert, David W. Wright, Victoria M. Scicluna, Deneil Harney, Robert Silbergleit, Kurt Denninghoff, Rebecca D. Pentz Tags: Biros Section on Research Ethics Source Type: research

Changing paradigms in organ preservation and resuscitation.
This article aims to review the recent advances in machine perfusion and organ preservation solutions. RECENT FINDINGS: Flow and pressure-based machine perfusion has shown improved kidney graft function and survival, especially among expanded criteria donors. Pressure-based machine perfusion is demonstrating promising results in preservation and resuscitation of liver, pancreas, heart, and also lung grafts. August 2014 marked Food and Drug Administration approval of XPS XVIVO Perfusion System (XVIVO Perfusion Inc., Englewood, Colorado, USA), a device for preserving and resuscitating lung allografts initially considered...
Source: Current Opinion in Organ Transplantation - February 25, 2015 Category: Transplant Surgery Authors: Ali F, Dua A, Cronin DC Tags: Curr Opin Organ Transplant Source Type: research

Tissue Engineered Constructs: Perspectives on Clinical Translation.
Abstract In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the ...
Source: Annals of Biomedical Engineering - February 25, 2015 Category: Biomedical Engineering Authors: Lu L, Arbit HM, Herrick JL, Segovis SG, Maran A, Yaszemski MJ Tags: Ann Biomed Eng Source Type: research

Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent.
Abstract In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of t...
Source: Accident and Emergency Nursing - February 25, 2015 Category: Emergency Medicine Authors: Biros MH, Dickert NW, Wright DW, Scicluna VM, Harney D, Silbergleit R, Denninghoff K, Pentz RD Tags: Acad Emerg Med Source Type: research

Two decades beyond BRCA1/2: homologous recombination, hereditary cancer risk and a target for ovarian cancer therapy.
Abstract Almost exactly twenty years after their discovery, the BRCA1 and BRCA2 genes have become the target of the first "personalized" therapy available for patients with ovarian cancer. In December 2014, a poly(ADP-ribose) polymerase (PARP) inhibitor was granted expedited approved by the United States Food and Drug Administration for use in advanced ovarian cancer patients with germline BRCA1/2 mutations who have received three or more prior lines of chemotherapy. This review article will discuss (1) the BRCA1 and BRCA2 genes within the larger context of homologous recombination deficiency; (2) the advances in o...
Source: Gynecologic Oncology - February 25, 2015 Category: Cancer & Oncology Authors: Walsh CS Tags: Gynecol Oncol Source Type: research

Electric Stimulation Device Approved to Treat Obesity
The US Food and Drug Administration (FDA) has approved a first-of-its-kind weight loss treatment device that electronically suppresses hunger signals traveling between the stomach and the brain (http://1.usa.gov/1yAbICk). The Maestro Rechargeable System, which is manufactured by EnteroMedics of St Paul, Minnesota, consists of an electrical pulse generator, wire leads, and electrodes that are implanted into the abdomen and intermittently send electrical pulses to the vagus nerve. (Source: JAMA)
Source: JAMA - February 24, 2015 Category: Journals (General) Source Type: research

Necessity of Magnetic Resonance Imaging Examinations After Permanent Pacemaker Implantation
Magnetic resonance imaging examinations (MRI) as a powerful diagnostic tool have dramatically increased. More than 370,000 patients received implantable device-based therapy in the USA in 2003[1]. However, patients receiving permanent pacemaker implantation (PMI) are contraindicated for MRI recommended by the U.S. Food and Drug Administration [1,2] and by device manufacturers [3–5]. There is an estimation that up to 75% of patients with pacemakers develop an indication for MRI over the lifetime of device owing to medical comorbidities [6,7] and an estimated 200,000 patients might have benefited from MRI. (Source: Interna...
Source: International Journal of Cardiology - February 24, 2015 Category: Cardiology Authors: Akira Taruya, Atsushi Tanaka, Tsuyoshi Nishiguchi, Tetsuya Iwaguro, Satoshi Ueno, Yasushi Okumoto, Takashi Kubo, Hideharu Akagi, Takashi Akasaka Tags: Letter to the Editor Source Type: research

Cardiovascular Pharmacogenomics; State of Current Knowledge and Implementation in Practice
Pharmacogenomics (PGx) is the science that examines how an individual's genetic make-up affects the safety and efficacy of therapeutic drugs. PGx of response to cardiovascular (CV) medications is of the most successfully translated branches of PGx into the clinical workout. However, the clinical implementation of PGx of CV drugs is yet far beyond the growth of our understanding of the role of genetics in drug therapy. A considerable amount of efforts have been devoted by the regulatory agents like the food and drug administration (FDA) as well as the expert-based networks such as the Clinical Pharmacogenetics Implementatio...
Source: International Journal of Cardiology - February 24, 2015 Category: Cardiology Authors: Payman Shahabi, Marie-Pierre Dubé Tags: Review Source Type: research

Stent Selection and Antiplatelet Therapy Duration One Size Does Not Fit All ∗
As a condition of approval for the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) in February 2008, the U.S. Food and Drug Administration considered, “the investigation of the optimal duration of dual antiplatelet therapy as a drug-eluting stent(s) (DES) class effect” (1). Despite this perspective, early comparative studies with ZES suggested that all stents were not equal. As the first drug-eluting stent (DES) compared in separate randomized trials against both bare-metal stent(s) (BMS) and first-generation sirolimus-eluting stent(s) (SES) and paclitaxel-eluting stent(s) (P...
Source: Journal of the American College of Cardiology - February 23, 2015 Category: Cardiology Source Type: research

Measles vaccination essential: Hamburg's outgoing words
Margaret A. Hamburg, M.D., outgoing commissioner of the Food and Drug Administration, had some strong final words for American consumers: if you or your children have not been vaccinated (or had measles), vaccination now is essential. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - February 23, 2015 Category: Psychiatry Tags: From the FDA Source Type: research

Long-term Nicotine Replacement Therapy A Randomized Clinical Trial
ImportanceThe US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks. This decision was based in part on data showing increased efficacy for 24 weeks of treatment. Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit.ObjectiveTo compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.Design, Setting, and ParticipantsWe recruited 525 treatment-seeking smokers for a randomized clinical trial conducted from June 22, 2009, through April 15,...
Source: JAMA Internal Medicine - February 23, 2015 Category: Internal Medicine Source Type: research

Prospects for a nicotine-reduction strategy in the cigarette endgame: alternative tobacco harm reduction scenarios
An innovative proposal made in 1994 (Benowitz & Henningfield, 1994) to mandate sales only of non-addictive, low-nicotine tobacco cigarettes has had a dominant place in cigarette endgame strategies and is encouraged by the American Medical Association, the British Medical Association, the U.S. Food and Drug Administration (FDA) and the U.S. Surgeon-General (Benowitz & Henningfield, 2013; Hatsukami, Benowitz, Donny, Henningfield, & Zeller, 2013; National Center for Chronic Disease Prevention and Health Promotion, 2014). (Source: International Journal of Drug Policy)
Source: International Journal of Drug Policy - February 23, 2015 Category: Addiction Authors: L.T. Kozlowski Tags: Research Paper Source Type: research

Protecting infants and children from chemical contaminants in food [FDA UPDATE]
(Source: AAP News)
Source: AAP News - February 23, 2015 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Office of Foods and Veterinary Medicine, Division of Pediatric & Maternal Health Tags: FDA Update, Nutrition Source Type: research

Response:
I agree that the bowel cleansing scale used in the trial1 comparing oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) is not validated. However, the scale definitions have substantial similarities to the Aronchick scale, and the scale has been accepted by the U.S. Food and Drug Administration (FDA) in pivotal trials.2,3 The key element in a bowel cleansing trial is blinding of the colonoscopists, which in this study was effective and complete. The blinded evaluations found that OSS produced superior cleansing compared with SP+MC. (Source: Gastrointestinal Endoscopy)
Source: Gastrointestinal Endoscopy - February 22, 2015 Category: Gastroenterology Authors: Douglas K. Rex Tags: Letter to the Editor Source Type: research

Breast carcinoma originating from a silicone granuloma: a case report
Breast carcinoma rarely occurs in cases of foreign body granulomas following liquid silicone injection. Although the Food and Drug Administration (FDA) banned the use of all silicone injection products in 1992, liquid silicone injection for breast augmentation continues to be performed illegally. We herein report a case of breast carcinoma following liquid silicone injection in a 67-year-old female.A total of 45 years after liquid silicone injection, the patient had felt a breast mass in the right breast. Mammography showed a smooth mass that retracted the right nipple. Due to the presence of a marked acoustic shadow caus...
Source: World Journal of Surgical Oncology - February 22, 2015 Category: Cancer & Oncology Authors: Ryoichi NakahoriRyuji TakahashiMomoko AkashiKana TsutsuiShino HaradaRoka MatsubayashiShino NakagawaSeiya MomosakiYoshito Akagi Source Type: research

Liquid chromatography tandem mass spectrometry quantitation of intracellular concentrations of ganciclovir and its phosphorylated forms.
The objective of this study was to develop a method to measure GCV and its derivatives in cells. A four-stage procedure was developed with the following strategy: (1) to separate into different fractions the different intracellular forms of GCV (GCV itself and its phosphorylated forms) by solid-phase extraction (SPE) from blood cells, (2) to dephosphorylate the different phosphorylated forms into GCV, (3) to perform a second SPE to desalt samples and concentrate GCV, and (4) to measure GCV concentrations in the different extracts using a triple-quadrupole, linear ion trap mass spectrometer. Finally, the procedure was teste...
Source: Analytical and Bioanalytical Chemistry - February 22, 2015 Category: Chemistry Authors: Billat PA, Sauvage FL, Picard N, Tafzi N, Alain S, Essig M, Marquet P, Saint-Marcoux F Tags: Anal Bioanal Chem Source Type: research

How does JAK2V617F contribute to the pathogenesis of myeloproliferative neoplasms?
Authors: Chen E, Mullally A Abstract A decade on from the discovery of the JAK2V617F mutation in the majority of patients with myeloproliferative neoplasms (MPNs), JAK2V617F is now firmly installed in the hematology curriculum of medical students and the diagnostic-testing algorithm of clinicians. Furthermore, the oral JAK1/JAK2 inhibitor ruxolitinib, rationally designed to target activated JAK2 signaling in MPN, has been approved by the Food and Drug Administration (FDA) of the United States for the past 3 years for the treatment of intermediate- and advanced-phase myelofibrosis. Notwithstanding this, JAK2V617F co...
Source: Hematology ASH Education Program - February 20, 2015 Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research

BCR pathway inhibition as therapy for chronic lymphocytic leukemia and lymphoplasmacytic lymphoma.
Authors: Wiestner A Abstract Chronic lymphocytic leukemia (CLL) and lymphoplasmacytic lymphoma (LPL) are malignancies of mature B cells. In LPL, mutations of the adaptor protein MYD88 (L265P) in the Toll-like receptor pathway have been recognized recently as being a hallmark of the disease and indicate a dependence of the tumor on this pathway. In CLL, functional studies have implicated BCR activation in the tissue microenvironment as a pivotal pathway in the pathogenesis. Bruton's tyrosine kinase (BTK) and the PI3Kδ isoform are essential for BCR signaling and also seem to be required for signal transduction in LP...
Source: Hematology ASH Education Program - February 20, 2015 Category: Hematology Tags: Hematology Am Soc Hematol Educ Program Source Type: research

Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling
This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords ‘smoke’, ‘smoker(s)’, ‘smoking’, ‘tobacco’ and ‘cigarette(s)’ on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 singl...
Source: Clinical Pharmacokinetics - February 20, 2015 Category: Drugs & Pharmacology Source Type: research

FDA's toothless tiger and its "lost pleasure" analysis
In 2009, amidst much fanfare, the United States Food and Drug Administration (FDA) was given the authority to regulate tobacco products when Congress passed the Family Smoking Prevention and Tobacco Control Act. Ostensibly, the Act provided the FDA with the legal authority to regulate the manufacturing, distribution, and marketing of tobacco products. There was a frisson of hope in some circles that at last, the process begun in the 1990s when David Kessler first attempted to regulate tobacco and was legally stymied by an industry lawsuit would finally come to fruition—and the makers of the world's most deadly consum...
Source: Tobacco Control - February 20, 2015 Category: Respiratory Medicine Authors: Malone, R. E. Tags: Editorial Source Type: research

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigaret...
Source: Tobacco Control - February 20, 2015 Category: Respiratory Medicine Authors: Chaloupka, F. J., Warner, K. E., Acemoglu, D., Gruber, J., Laux, F., Max, W., Newhouse, J., Schelling, T., Sindelar, J. Tags: Open access Special communication Source Type: research

Assessing tobacco regulation: moving beyond economists
US presidents since Ronald Reagan have required regulatory agencies to conduct cost-benefit analyses of proposed regulations,1 currently governed by Office of Management and Budget Circular A-4.2 On its surface, requiring such analyses makes sense; after all, why burden businesses with costly regulations if there is little benefit to the public? There are, however, several problems with cost-benefit analysis, including the facts that the costs are often borne by different people than receive the benefits, the tendency of cost-benefit analysis to overstate costs and understate benefits and the pro-business bias within the e...
Source: Tobacco Control - February 20, 2015 Category: Respiratory Medicine Authors: Song, A. V., Glantz, S. A. Tags: Special communication Source Type: research

Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program.
This report outlines recommendations for the clinical use of the three smallpox vaccines stored in the U.S. Strategic National Stockpile for persons who are exposed to smallpox virus or at high risk for smallpox infection during a postevent vaccination program following an intentional or accidental release of the virus. No absolute contraindications exist for smallpox vaccination in a postevent setting. However, several relative contraindications exist among persons with certain medical conditions. CDC recommendations for smallpox vaccine use were developed in consideration of the risk for smallpox infection, risk for an a...
Source: MMWR Recomm Rep - February 20, 2015 Category: Epidemiology Authors: Petersen BW, Damon IK, Pertowski CA, Meaney-Delman D, Guarnizo4 JT, Beigi RH, Edwards KM, Fisher MC, Frey SE, Lynfield R, Willoughby RE Tags: MMWR Recomm Rep Source Type: research

Outbreak of salmonella newport infections linked to cucumbers - United States, 2014.
Abstract In August 2014, PulseNet, the national molecular subtyping network for foodborne disease surveillance, detected a multistate cluster of Salmonella enterica serotype Newport infections with an indistinguishable pulse-field gel electrophoresis (PFGE) pattern (XbaI PFGE pattern JJPX01.0061). Outbreaks of illnesses associated with this PFGE pattern have previously been linked to consumption of tomatoes harvested from Virginia's Eastern Shore in the Delmarva region and have not been linked to cucumbers or other produce items. To identify the contaminated food and find the source of the contamination, CDC, state...
Source: MMWR Morb Mortal Wkl... - February 20, 2015 Category: Epidemiology Authors: Angelo KM, Chu A, Anand M, Nguyen TA, Bottichio L, Wise M, Williams I, Seelman S, Bell R, Fatica M, Lance S, Baldwin D, Shannon K, Lee H, Trees E, Strain E, Gieraltowski L Tags: MMWR Morb Mortal Wkly Rep Source Type: research

Clinical Trials: A Need to Better Define the Control Group as Current Standard of Care
So far, there have been 2 clinical trials leading to Food and Drug Administration (FDA) approval of anti–vascular endothelial growth factor (VEGF) therapy for macular edema resulting from branch retinal vein occlusion (BRVO). The first was the BRAVO (RanibizumaB for the treatment of macular edema following BRAnch Retinal Vein Occlusion) trial1 for ranibizumab, and the second was the VIBRANT2 (See page 538) trial for aflibercept. Reading the VIBRANT trial report raised several questions, which led me to re-read the BRAVO trial report carefully and put pen to paper. (Source: Ophthalmology)
Source: Ophthalmology - February 19, 2015 Category: Opthalmology Authors: Sophie J. Bakri Tags: Editorial Source Type: research

Intraperitoneal administration of activated protein C prevents postsurgical adhesion band formation
In this study, we used a mouse model of adhesion and compared the protective effect of activated protein C (APC) to that of the Food and Drug Administration–approved antiadhesion agent, sodium hyaluronate/carboxymethylcellulose (Seprafilm) by intraperitoneal administration of either APC or Seprafilm to experimental animals. Pathological adhesion bands were graded on day 7, and peritoneal fluid concentrations of tissue plasminogen activator (tPA), d-dimer, thrombin–antithrombin complex, and cytokines (IL-1β, IL-6, interferon-, tumor necrosis factor-α, transforming growth factor-β1) were evaluated...
Source: Blood - February 19, 2015 Category: Hematology Authors: Dinarvand, P., Hassanian, S. M., Weiler, H., Rezaie, A. R. Tags: Thrombosis and Hemostasis, Vascular Biology Source Type: research

Treatment of Hemophilia in the Near Future
Semin Thromb HemostDOI: 10.1055/s-0034-1543998Advancements and debacles have characterized hemophilia treatment over the past 50 years. The 1970s saw the availability of plasma-derived concentrates making prophylaxis and home therapy possible. This optimistic perception changed extremely in the early 1980s, when most people with hemophilia were infected with HIV and hepatitis viruses. Then, also in the 1980s, the rapid progress in molecular biology led to the development of recombinant therapeutic products. This important advancement was a huge technological leap fresh off from the earlier 1980s disaster. Now in the 21st c...
Source: Seminars in Thrombosis and Hemostasis - February 19, 2015 Category: Hematology Authors: Peyvandi, FloraGaragiola, Isabella Source Type: research