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Brand-Name Medications vs Available Generic Alternatives
In December 1996, 8 days before Christmas, the US Food and Drug Administration (FDA) approved Lipitor (atorvastatin; Pfizer) for the treatment of hyperlipidemia. Lipitor would become one of the most profitable prescription drugs in history, bringing in $130 billion in sales during its lifetime as a brand-name product and peaking at nearly $13 billion in sales in 2006 alone. Lipitor was far from the first statin in its class (simvastatin, pravastatin, and fluvastatin were already on the market), but 1996 was also the year that the FDA began allowing direct-to-consumer broadcast advertising. Lipitor was aggressively marketed...
Source: JAMA Internal Medicine - June 27, 2016 Category: Internal Medicine Source Type: research

A New Level A Type IVIVC for the Rational Design of Clinical Trials Toward Regulatory Approval of Generic Polymeric Long-Acting Injectables
Abstract Chronic neuropsychiatric disorders and diabetes mellitus affect millions of patients and require long-term supervision and expensive medical care. Although repeated drug administration can help manage these diseases, relapses and re-hospitalization owing to patient non-adherence and reduced therapeutic efficacy remain challenging. In response, long-acting injectables, which provide sustained drug release over longer periods at concentrations close to therapeutic ranges, have been proposed. Recent advancements include polymeric long-acting injectables (pLAIs), in which the active pharmaceutical ingredient ...
Source: Clinical Pharmacokinetics - June 27, 2016 Category: Drugs & Pharmacology Source Type: research

Voriconazole
(VCZ) is a second generation triazole that is an antifungal agent used in human and veterinary medicine to treat systemic fungal infections. Approved by the United States Food and Drug Administration (USFDA) in 2002, it is a synthetic derivative of fluconazole with changes to the chemical structure that resulted in a greater antifungal spectrum when compared to fluconazole.1 In human medicine, VCZ has an enhanced spectrum of activity that includes Candida spp., Aspergillus spp., Cryptococcus spp., dimorphic fungi (e.g., Blastomyces dermatitidis, Coccidioides immitis, Histoplasma capsulatum), and filamentous fungi (e.g., F...
Source: Journal of Exotic Pet Medicine - June 27, 2016 Category: Veterinary Research Authors: Richard R. Sim Source Type: research

Review: Stent Fracture in the Drug-Eluting Stent Era
Stent fracture has been recognized as one cause of stent failure and has been associated with in-stent restenosis and stent thrombosis, even in 2nd-generation drug-eluting stents. Given the wide use of drug-eluting stents and paucity of contemporary data available concerning stent fracture, we reviewed clinical studies and the Food and Drug Administration's Manufacturer and User Device Experience (MAUDE) database to analyze the current trends, mechanisms, predictors, outcomes and treatment for stent fracture. (Source: Cardiovascular Revascularization Medicine)
Source: Cardiovascular Revascularization Medicine - June 27, 2016 Category: Cardiology Authors: Alfazir Omar, Lakshmana K. Pendyala, John A. Ormiston, Ron Waksman Source Type: research

Challenges in Measuring Cost and Value in Oncology: Making It Personal
Oncology patients often find themselves facing an incurable disease with limited treatment options and increasing patient fragility. The importance of patient preferences and values increases in shared decision making especially when the cost of cancer care is continuing its steep rise. As our understanding of cancer systems biology increases, we are justifiably optimistic about therapeutic improvements but recognize that this has complicated the traditional Food and Drug Administration approval of drug indications based on organ-specific cancer for a particular drug. (Source: Value in Health)
Source: Value in Health - June 27, 2016 Category: Global & Universal Authors: Peter P. Yu Source Type: research

Questionable oncologic benefits of degarelix
Luteinizing hormone releasing hormone (LhRh) antagonist degarelix has been approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer in 2008. However, the studies that followed such initial approval have several limitations. (Source: Urologic Oncology: Seminars and Original Investigations)
Source: Urologic Oncology: Seminars and Original Investigations - June 27, 2016 Category: Urology & Nephrology Authors: Fernando P. Secin Tags: News and Topics Source Type: research

Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study
The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. Summary of Background Data. i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. Methods. Patients randomly received either autograft (N = 154) or i-Factor (N = 1...
Source: Spine - June 25, 2016 Category: Orthopaedics Tags: Randomized Trial Source Type: research

Measuring the efficiency of large pharmaceutical companies: an industry analysis
We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms—taking into consideration the strategic importance of R&D—suggest that the pharmaceutical industry is a highly competitive sector given that there a...
Source: The European Journal of Health Economics - June 25, 2016 Category: Health Management Source Type: research

New Warnings for Opioid Analgesics
* The Food and Drug Administration is revising the labeling of all opioid analgesics to warn that interactions between opioids and serotonergic drugs can produce serotonin syndrome, opioids have been linked to adrenal insufficiency, and decreases in levels of sex hormones may be associated with opioid use. (Source: AJN)
Source: AJN - June 24, 2016 Category: Nursing Tags: Drug Watch Source Type: research

Green’s Child and Adolescent Clinical Psychopharmacology
The first edition of Green’s Child and Adolescent Clinical Psychopharmacology was published in 1991. Since then, pediatric psychopharmacology has exploded with the approval of novel agents and additional indications for existing agents. In the preface, the editors of the fifth edition state that the text maintains Dr. Green’s attention to Food and Drug Administration (FDA) black box and bold print warnings. In addition, the format is similar to previous editions, but with some exceptions: changes include the grouping of medications used to enhance attention into 1 chapter and coverage of less commonly used drugs in an ...
Source: Journal of the American Academy of Child and Adolescent Psychiatry - June 24, 2016 Category: Psychiatry Authors: Liberty Fritzler, Deepak Prabhakar Tags: Book forum Source Type: research

Pathway for surgeons and programs to establish and maintain a successful robot-assisted adult cardiac surgery program
Robotic cardiac surgery is defined as any cardiac operation that is performed either completely or in part using robot-assisted (ie, telemanipulation) technology. At present, for robot-assisted cardiac operations, the Food and Drug Administration (FDA) has approved only one device, the da Vinci surgical system (Intuitive Surgical, Sunnyvale, Calif). (Source: The Journal of Thoracic and Cardiovascular Surgery)
Source: The Journal of Thoracic and Cardiovascular Surgery - June 22, 2016 Category: Cardiovascular & Thoracic Surgery Authors: Evelio Rodriguez, L. Wiley Nifong, Johannes Bonatti, Roberto Casula, Volkmar Falk, Thierry A. Folliguet, Bob B. Kiaii, Michael J. Mack, Tomislav Mihaljevic, J. Michael Smith, Rakesh M. Suri, Joseph E. Bavaria, Thomas E. MacGillivray, W. Randolph Chitwood Tags: Editorial: Cardiac: Robotic Source Type: research

Cantharidin in Dermatology.
Abstract Cantharidin is natural toxin produced by the blistering beetle. It has both vesicant and keratolytic features by inducing acanthloysis through targeting the desmosomal dense plaque, leading to detachment of the desmosomes from the tonofilaments. There are two available liquid preparations for dermatologic use, Canthacur (0.7% cantharidin) and Canthacur PS (1% cantharidin 30%/salicylic acid/2% podophylotoxin). The former preparation is indicated for the treatment of common warts, periungual warts, and molluscum contagiosum, while the more potent latter preparation is indicated only for plantar warts. Both p...
Source: Skinmed - June 22, 2016 Category: Dermatology Authors: Al-Dawsari NA, Masterpol KS Tags: Skinmed Source Type: research

Recent advances in abuse-deterrent technologies for the delivery of opioids
This article provides a comprehensive review of the material sciences principles that govern the formulation and processing of a wide range of abuse-deterrent products and technologies. Graphical abstract (Source: International Journal of Pharmaceutics)
Source: International Journal of Pharmaceutics - June 22, 2016 Category: Drugs & Pharmacology Source Type: research

Targeted Therapeutics in Patients With High-Grade Gliomas: Past, Present, and Future
Opinion statement High-grade gliomas remain incurable despite current therapies, which are plagued by high morbidity and mortality. Molecular categorization of glioma subtypes using mutations in isocitrate dehydrogenase 1/2 (IDH1/2), TP53, and ATRX; codeletion of chromosomes 1p and 19q; DNA methylation; and amplification of genes such as epidermal growth factor receptor (EGFR) and platelet-derived growth factor receptor, alpha polypeptide provides a more accurate prognostication and biologic classification than classical histopathological diagnoses, and a number of molecular markers are being incorporated in the ...
Source: Current Treatment Options in Oncology - June 22, 2016 Category: Cancer & Oncology Source Type: research

In Reply
More and more evidence indicates that mefloquine potentially causes long-term mental health problems.1 And the U.S. Food and Drug Administration has recently added a boxed warning to mefloquine, advising of the possibility of neurologic and psychiatric adverse events even after drug withdrawal. We are quite sympathetic to Dr. Nevin’s proposals of considerations in the repositioning of mefloquine for an anesthetic. However, we have our own opinion about considering mefloquine, or its ameliorated form, as a potential analgesic candidate in the future. (Source: Anesthesiology)
Source: Anesthesiology - June 21, 2016 Category: Anesthesiology Source Type: research

Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis.
Authors: Nguyen T, Cao T, Akkerman OW, Tiberi S, Vu DH, Alffenaar J Abstract INTRODUCTION: Few innovative anti-microbial products have been brought to market in recent years to combat the global multidrug resistant-tuberculosis (MDR-TB) epidemic. Bedaquiline, a novel oral diarylquinoline, was approved by the US FDA as a part of combination therapy in adults with pulmonary MDR-TB based on phase II trials. AREA COVERED: Pubmed searches were conducted using search terms bedaquiline, diarylquinoline, R207910, and TMC207 was performed. Supplementary sources included World Health Organization, Clinicaltrial.gov, US F...
Source: Expert Review of Clinical Pharmacology - June 21, 2016 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Bard Denali Filter Fractures
The Denali filter (Bard Peripheral Vascular, Inc, Tempe, Arizona) gained US Food and Drug Administration (FDA) approval and was launched in 2013 as the most recent iteration of the prior C.R. Bard line of filters, which successively includes the Recovery, G2, G2 Express, Eclipse, and Meridian. Fracture of struts across this family of inferior vena cava (IVC) filters is known; for example, the Bard G2 has an estimated 5-year fracture prevalence of 38% (1). A review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database revealed that 27% of complications reported for Bard IVC filters was related to frac...
Source: Journal of Vascular and Interventional Radiology : JVIR - June 21, 2016 Category: Radiology Authors: Bill S. Majdalany, Minhajuddin S. Khaja, David M. Williams Tags: Letter to the Editor Source Type: research

Design Considerations for Artificial Pancreas Pivotal Studies
The development of artificial pancreas systems has evolved to the point that pivotal studies designed to assess efficacy and safety are in progress or soon to be initiated. These pivotal studies are intended to provide the necessary data to gain clearance from the U.S. Food and Drug Administration, coverage by payers, and adoption by patients and clinicians. Although there will not be one design that is appropriate for every system, there are certain aspects of protocol design that will be considerations in all pivotal studies designed to assess efficacy and safety. One key aspect of study design is the intervention to be ...
Source: Diabetes Care - June 21, 2016 Category: Endocrinology Authors: Russell, S. J.; Beck, R. W. Tags: The Artificial Pancreas in 2016: A Digital Treatment Ecosystem for Diabetes Source Type: research

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System. Final order.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System. Final order. Fed Regist. 2016 Jun 21;81(119):40181-3 Authors: Food and Drug Administration, HHS Abstract The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system 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 gynecologic laparoscopic power morcellation containment system's classifica...
Source: Fed Regist - June 21, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Fish Intake During Pregnancy and Offspring Adiposity
To the Editor I read with great interest the article by Stratakis et al in JAMA Pediatrics. In a large pooled analysis of 15 population-based birth cohorts in Europe and the United States, Stratakis et al found that high maternal fish consumption (>3 times/week) during pregnancy was associated with increased risk of rapid growth in infancy and childhood overweight/obesity at ages 4 years and 6 years. These findings were in line with the US Food and Drug Administration and Environmental Protection Agency’s updated advice on fish consumption for pregnant women. However, it is noteworthy that the US Food and Drug Administra...
Source: JAMA Pediatrics - June 20, 2016 Category: Pediatrics Source Type: research

Monitoring Antimicrobial Resistance in the Food Supply Chain and its Implications for FDA Policy Initiatives.
We examined the trends in both AMR proportion and minimum inhibitory concentration (MIC) between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinalone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years not be...
Source: Antimicrobial Agents and Chemotherapy - June 20, 2016 Category: Microbiology Authors: Zawack K, Li M, Booth JG, Love W, Lanzas C, Gröhn YT Tags: Antimicrob Agents Chemother Source Type: research

FDA approves first cholera vaccine for travelers
The Food and Drug Administration has approved a vaccine for the prevention of cholera caused by serogroup O1 in adults aged 18-64 years traveling to cholera-affected areas. The vaccine, known as... (Source: Internal Medicine News)
Source: Internal Medicine News - June 18, 2016 Category: Internal Medicine Source Type: research

Use of the Wearable Cardioverter Defibrillator in High-Risk Populations
Abstract The United States Food and Drug Administration has approved the wearable cardioverter defibrillator (WCD) for use in patients who are at high risk for sudden cardiac arrest (SCA) and who do not yet have an established indication for an implantation cardioverter defibrillator (ICD) or have contraindications for device implantation for various reasons. The WCD is typically used for primary prevention in (1) high-risk patients with reduced left ventricular ejection fraction (LVEF) ≤35 % after recent acute myocardial infarction (MI) during the 40-day ICD waiting period, (2) before and after coronary arter...
Source: Current Cardiology Reports - June 18, 2016 Category: Cardiology Source Type: research

Weight loss device that removes food from stomach approved for use in the US
A device which allows people to pump out food from their stomach after every meal via a surgically placed tube has been approved for the management of obesity by the US Food and Drug Administration (FDA). (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - June 17, 2016 Category: Drugs & Pharmacology Source Type: research

FDA Boxed Warning for Immediate-Release Opioids.
Authors: Food And Drug Administration Public Health Service U S Department Of Health And Human Services Abstract On March 22, 2016, the Food and Drug Administration (FDA) announced enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death. The new safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use. PMID: 27301692 [PubMed - in process] (Source: Journal of Pain and Palliative Care Pharmacotherapy)
Source: Journal of Pain and Palliative Care Pharmacotherapy - June 17, 2016 Category: Palliative Care Tags: J Pain Palliat Care Pharmacother Source Type: research

Prednisone and Deflazacort in Duchenne Muscular Dystrophy: Do They Play a Different Role in Child Behavior and Perceived Quality of Life?
In this study, we only used the syndrome scales of the CBCL. Syndromes are sets of concurrent problems that tend to co-occur together. Syndrome scales include anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior. Syndrome scales are categorized into internalizing and externalizing behaviors. Internalizing behaviors are problems that are primarily within the individual and include anxious/depressed, withdrawn/depressed and somatic complaints, while externalizing behaviors are problems that mainly involve conflict wit...
Source: PLOS Currents Muscular Dystrophy - June 17, 2016 Category: Neurology Authors: Susan Sienko Source Type: research

Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled.
Authors: Saluja S, Woolhandler S, Himmelstein DU, Bor D, McCormick D Abstract For some drugs, safety concerns are only discovered after they have been on the market, sometimes for several years. The U.S. Food and Drug Administration (FDA) has adopted several policies that could increase the likelihood of approving a potentially unsafe medication. We attempted to quantify the number of exposures in the United States to drugs that were newly approved but later withdrawn from the market. We obtained a list of all drugs approved and subsequently withdrawn from the U.S. market due to safety concerns between 1993 and 201...
Source: International Journal of Health Services - June 17, 2016 Category: Health Management Tags: Int J Health Serv Source Type: research

Prescribing Medications for Pain Relief: Doctors, Patients, and Federal Regulators
In a recent New York Times editorial titled “The Opioid Epidemic We Failed to Foresee,” David A. Kessler, MD, former commissioner of the U.S. Food and Drug Administration from 1990 to 1997, argued that one of the biggest mistakes of modern medicine was its failure to appreciate the addictive nature of opioid analgesics (1). Dr. Kessler referred to a campaign by the pharmaceutical industry in the 1990s to push the idea that patients would not develop an addiction to opiate use no matter how long they took them. (Source: Journal of Foot and Ankle Surgery)
Source: Journal of Foot and Ankle Surgery - June 17, 2016 Category: Orthopaedics Authors: D. Scot Malay Tags: Editorial Source Type: research

[Editorial] Self-medicating in the opioid crisis
On June 7, the US Food and Drug Administration released a drug safety notice about loperamide, an anti-diarrhoea medicine sold over the counter and under prescription. The drug is being used as a cheap and legally-available high, and to reduce the symptoms of opioid withdrawal. A standard dose for the medicine is 8 mg per day in divided doses, but opioid users have been taking massive doses of the drug, as much as 300 mg or more daily for weeks at a time. Taken in such high quantities, overdoses of loperamide can cause severe heart problems like ventricular arrhythmias, cardiac arrest, and death. (Source: LANCET)
Source: LANCET - June 17, 2016 Category: Journals (General) Authors: The Lancet Tags: Editorial Source Type: research

Human factors in healthcare: welcome progress, but still scratching the surface
Introduction Calls to integrate human factors and ergonomics (HFE) within healthcare and patient safety have become increasingly frequent in the last few years.1 Judging by the number of recent articles in BMJ Quality and Safety that focus on HFE,2–4 we seem to be a step closer to achieving this goal. Within the USA and UK, groups such as the Human Factors and Ergonomics Society (HFES), the Chartered Institute of Human Factors and Ergonomics (CIEHF) and the Clinical Human Factors Group (CHFG) are also making significant progress in working with clinicians, healthcare managers and patients. Developments such as the UK...
Source: BMJ Quality and Safety - June 17, 2016 Category: Journals (General) Authors: Waterson, P., Catchpole, K. Tags: Viewpoints Source Type: research

Re-Evaluating Progression in an Era of Progress: A Review of First- and Second-Line Treatment Options in Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer
The advent of crizotinib, the first small molecule inhibitor against anaplastic lymphoma kinase (ALK), has led to impressive advances in the care of patients with advanced ALK-rearranged non-small cell lung cancer. The development of second-generation ALK inhibitors, starting with the recent U.S. Food and Drug Administration approval of ceritinib, promises to expand the therapeutic landscape for this cohort of patients. With increasing use of molecularly targeted therapy options, it has been observed that disease progression in patients receiving targeted agents has a heterogeneous biology, manifesting as either oligoprogr...
Source: The Oncologist - June 17, 2016 Category: Cancer & Oncology Authors: Castellanos, E. H., Horn, L. Tags: Review, Lung Cancer Source Type: research

Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality
Publication date: 25 July 2016 Source:International Journal of Pharmaceutics, Volume 509, Issues 1–2 Author(s): Thomas F. O’Connor, Lawrence X. Yu, Sau L. Lee Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufact...
Source: International Journal of Pharmaceutics - June 17, 2016 Category: Drugs & Pharmacology Source Type: research

A new algorithmic approach for the extraction of temporal associations from clinical narratives with an application to medical product safety surveillance reports
In this study, we focus on medical product safety report narratives and investigate the association of the clinical events with appropriate time information. We developed a novel algorithm for tagging and extracting temporal information from the narratives, and associating it with related events. The proposed algorithm minimizes the performance dependency on text quality by relying only on shallow syntactic information and primitive properties of the extracted event and time entities. We demonstrated the effectiveness of the proposed algorithm by evaluating its tagging and time assignment capabilities on 140 randomly selec...
Source: Journal of Biomedical Informatics - June 17, 2016 Category: Information Technology Source Type: research

DNA Repair Deficiency Is Common in Advanced Prostate Cancer: New Therapeutic Opportunities.
This article discusses the current understanding of the genomic landscape of prostate cancer, focusing on the occurrence of DNA repair mutations and the therapeutic opportunities that this presents. IMPLICATIONS FOR PRACTICE: This review aims to update oncologists about the increased understanding of the genomes of prostate cancers and, in particular, the prevalence of mutations in DNA repair genes. These observations provide potential new therapeutic opportunities for the use of poly(ADP-ribose) polymerase inhibitors and other therapies, especially in advanced forms of the disease. Of note is the recent U.S. Food and ...
Source: The Oncologist - June 17, 2016 Category: Cancer & Oncology Authors: Dhawan M, Ryan CJ, Ashworth A Tags: Oncologist Source Type: research

Reporting Cosmetic Adverse Events to the US Food and Drug Administration.
PMID: 27323232 [PubMed - as supplied by publisher] (Source: Dermatitis)
Source: Dermatitis - June 17, 2016 Category: Dermatology Authors: Katz LM, Valenzuela C, Sadrieh NK Tags: Dermatitis Source Type: research

Tips for collaborations among GI investigators, industry, FDA
SAN DIEGO – Tensions among academic investigators, industry sponsors, and the Food and Drug Administration can hinder new drug approvals and slow or block communication of important results, experts... (Source: Internal Medicine News)
Source: Internal Medicine News - June 16, 2016 Category: Internal Medicine Source Type: research

Calls Escalate for Lifting Blood Donor Ban on Men Who Have Sex with Men
After the Orlando massacre some are suggesting the Food and Drug Administration reconsider its policy -- Read more on ScientificAmerican.com (Source: Scientific American)
Source: Scientific American - June 16, 2016 Category: Science Authors: Mindy WeisbergerLiveScience Tags: Health Public Health Policy & Ethics Source Type: research

The Food and Drug Administration Approves Panoply of Medical Device Products
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - June 16, 2016 Category: Medical Equipment Tags: DEPARTMENTS: Washington Scene Source Type: research

A hard look at FDA's review of GRAS notices
Publication date: Available online 16 June 2016 Source:Regulatory Toxicology and Pharmacology Author(s): Ashley Roberts, Lois A. Haighton Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of “reasonable certainty of no harm” is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of “FDA has no questio...
Source: Regulatory Toxicology and Pharmacology - June 16, 2016 Category: Toxicology Source Type: research

FDA issues warning over loperamide heart risks
The US Food and Drug Administration (FDA) has issued a warning that high doses of the anti-diarrheal medication loperamide are associated with a risk of heart problems. (Source: The Pharmaceutical Journal)
Source: The Pharmaceutical Journal - June 15, 2016 Category: Drugs & Pharmacology Source Type: research

Trans fatty acids and cardiovascular risk: does origin matter?
Authors: Dawczynski C, Lorkowski S Abstract Several studies have aimed to unravel the contribution of different types of dietary fatty acids to human health and disease. Investigations have consistently shown that high consumption of industrially produced trans-fatty acids from partially hydrogenated vegetable oils is harmful to human health, in particular cardiovascular health. Therefore, the U.S. Food and Drug Administration announced that partially hydrogenated oils are no longer 'generally recognized as safe', and trans-fatty acids are not permitted in the U.S. food supply. On the other hand, recent studies ana...
Source: Expert Review of Cardiovascular Therapy - June 15, 2016 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

FDA strengthens kidney warnings on two diabetes drugs
The Food and Drug Administration has revised warnings on certain medications for type 2 diabetes mellitus based on recent reports of... (Source: Internal Medicine News)
Source: Internal Medicine News - June 15, 2016 Category: Internal Medicine Source Type: research

DrugE-Rank: improving drug-target interaction prediction of new candidate drugs or targets by ensemble learning to rank
Motivation: Identifying drug–target interactions is an important task in drug discovery. To reduce heavy time and financial cost in experimental way, many computational approaches have been proposed. Although these approaches have used many different principles, their performance is far from satisfactory, especially in predicting drug–target interactions of new candidate drugs or targets. Methods: Approaches based on machine learning for this problem can be divided into two types: feature-based and similarity-based methods. Learning to rank is the most powerful technique in the feature-based methods. Similarity...
Source: Bioinformatics - June 15, 2016 Category: Bioinformatics Authors: Yuan, Q., Gao, J., Wu, D., Zhang, S., Mamitsuka, H., Zhu, S. Tags: APPLIED BIOINFORMATICS Source Type: research

Development of ciclopirox nail lacquer with enhanced permeation and retention.
Abstract Onychomycosis is a prevailing disease caused by fungal infection of nails that mostly affects athletes and the elderly. Ciclopirox is approved by the US Food and Drug Administration for the topical treatment of onychomycosis. However, the desired penetration of ciclopirox into the nail bed has not been achieved via topical application for efficient treatment. Therefore, the main aim of this study was to enhance ciclopirox permeation and retention in nail by the development of a new nail lacquer formulation. We screened the effects of different solvents, alkalizing agents, and permeation enhancers on the pe...
Source: Archives of Pharmacal Research - June 15, 2016 Category: Drugs & Pharmacology Authors: Thapa RK, Choi JY, Go TG, Kang MH, Han SD, Jun JH, Son MW, Yong CS, Kim JO Tags: Arch Pharm Res Source Type: research

Use of Symbols in Labeling. Final rule.
Abstract The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to all...
Source: Fed Regist - June 15, 2016 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

A hard look at FDA's review of GRAS notices.
Abstract Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U.S. Food and Drug Administration (FDA) GRAS notice process. Under the GRAS notice process, pivotal safety data are required to be in the public domain, and consensus of safety among experts is required. FDA issues responses of "FDA has no questions", "Notice does not provide a basis for a GRAS determination", or, "At Notifier's request, FDA ceased to evaluate the notice." Of...
Source: Regulatory Toxicology and Pharmacology : RTP - June 15, 2016 Category: Toxicology Authors: Roberts A, Haighton LA Tags: Regul Toxicol Pharmacol Source Type: research

FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science.
Abstract Here, we provide a concise overview of US Food and Drug Administration (FDA) drug labeling, which details drug products, drug-drug interactions, adverse drug reactions (ADRs), and more. Labeling data have been collected over several decades by the FDA and are an important resource for regulatory research and decision making. However, navigating through these data is challenging. To aid such navigation, the FDALabel database was developed, which contains a set of approximately 80000 labeling data. The full-text searching capability of FDALabel and querying based on any combination of specific sections, docu...
Source: Drug Discovery Today - June 15, 2016 Category: Drugs & Pharmacology Authors: Fang H, Harris SC, Liu Z, Zhou G, Zhang G, Xu J, Rosario L, Howard P, Tong W Tags: Drug Discov Today Source Type: research

A review of 2015 drug approvals: Safety in pregnancy and lactation
The Food and Drug Administration approved 45 new drugs in 2015. Currently, lesinurad (Zurampic) to treat high blood uric levels associated with gout, is not yet available. Another agent, aripiprazole... (Source: Ob.Gyn. News)
Source: Ob.Gyn. News - June 14, 2016 Category: OBGYN Source Type: research

Biosimilars: Extrapolation for oncology
Biologics are essential and widely used in cancer treatment as therapeutic agents (e.g., monoclonal antibodies [mAbs]) and as supportive care agents (e.g., growth factors). Because biologics are inherently variable complex molecules that are produced through manufacturing processes in living cells, they cannot be duplicated identically to a level typically possible for small molecule drugs. Hence, the term “biosimilar” is used to describe a biologic that is highly similar to a licensed biologic product (the reference product) (European Medicines Agency, 2014; US Food and Drug Administration, 2015; World Health Organiza...
Source: Critical Reviews in Oncology Hematology - June 14, 2016 Category: Cancer & Oncology Authors: Giuseppe Curigliano, Darran P. O’Connor, Julie A. Rosenberg, Ira Jacobs Source Type: research

Transfusion-transmitted malaria not preventable by current blood donor screening guidelines: a case report.
We present a case of TTM not preventable by these guidelines. CASE REPORT: A 76-year-old male presented with fever, hypotension, tachycardia, and a urinalysis consistent with a urinary tract infection. He was admitted to the intensive care unit and initiated on broad-spectrum antibiotics. On Hospital Day 2, he was incidentally found to have intraerythrocytic parasites on a peripheral smear, identified as Plasmodium malariae by polymerase chain reaction and was treated successfully with atovaquone-proguanil. The patient had no recent foreign travel or exposure to malaria but had received 15 units of blood products in t...
Source: Transfusion - June 13, 2016 Category: Hematology Authors: Holtzclaw A, Mrsic Z, Managbanag J, Calvano T, Colombo C Tags: Transfusion Source Type: research