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Management: Food and Drug Administration (FDA)

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Total 15351 results found since Jan 2013.

Improving the Effect of FDA-Mandated Drug Safety Alerts with Internet-Based Continuing Medical Education.
Abstract The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear Healthcare Provider (DHCP) letter mandated for distri...
Source: Current Drug Safety - May 7, 2013 Category: Drugs & Pharmacology Authors: Kraus CN, Baldwin AT, McAllister RG Tags: Curr Drug Saf Source Type: research

Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy
Dermatologists are frequently faced with questions about the safety of commonly prescribed topical and systemic medications during pregnancy and lactation from women of childbearing age who are pregnant, considering pregnancy, or breastfeeding. Safety data, particularly regarding medications that are unique to dermatology, can be difficult to locate and are not consolidated in a single reference guide for clinicians. Parts I and II of this continuing medical education article provide a capsule summary of key points for the most commonly prescribed dermatologic medications to facilitate patient medication risk counseling in...
Source: Journal of the American Academy of Dermatology - February 19, 2014 Category: Dermatology Authors: Jenny E. Murase, Misha M. Heller, Daniel C. Butler Tags: Continuing Medical Education Source Type: research

Onychomycosis
is a fungal nail infection caused by dermatophytes, nondermatophytes, and yeast, and is the most common nail disorder seen in clinical practice. It is an important problem because it may cause local pain, paresthesias, difficulties performing activities of daily living, and impair social interactions. The epidemiology, risk factors, and clinical presentation and diagnosis of onychomycosis were discussed in the first article in this continuing medical education series. In this article, we review the prognosis and response to onychomycosis treatment, medications for onychomycosis that have been approved by the US Food and D...
Source: Journal of the American Academy of Dermatology - June 26, 2018 Category: Dermatology Authors: Shari R. Lipner, Richard K. Scher Tags: Continuing medical education Source Type: research

Prurigo nodularis
(PN) is a chronic inflammatory skin disease characterized by intensely pruritic, hyperkeratotic nodules that favor the extensor surfaces of the extremities and the trunk. In addition to its significant impact on quality of life, many patients with PN are recalcitrant to therapy because there are currently no therapies approved by the US Food and Drug Administration. In the first article of this 2-part continuing medical education series, we describe the broader epidemiology, patient demographics, physical examination findings, and symptoms to aid in the timely recognition and diagnosis of PN.
Source: Journal of the American Academy of Dermatology - May 23, 2020 Category: Dermatology Authors: Amy H. Huang, Kyle A. Williams, Shawn G. Kwatra Tags: Continuing medical education Source Type: research

Reflectance confocal microscopy
(RCM) is a high-resolution, noninvasive tool that is currently approved by the US Food and Drug Administration for obtaining and interpreting images of the skin and cutaneous neoplasms with the goal of decreasing unnecessary biopsy procedures in patients with benign lesions. The second article in this continuing medical education series focuses on identifying key criteria for the diagnosis of common skin cancers —melanoma, basal cell carcinoma, and squamous cell carcinoma.
Source: Journal of the American Academy of Dermatology - June 17, 2020 Category: Dermatology Authors: Neda Shahriari, Jane M. Grant-Kels, Harold Rabinovitz, Margaret Oliviero, Alon Scope Tags: Continuing medical education Source Type: research

Metric-based simulation training to proficiency in medical education:- What it is and how to do it.
Abstract High profile error cases and reduced work hours have forced medicine to consider new approaches to training. Simulation-based learning for the acquisition and maintenance of skills has a growing role to play. Considerable advances have been made during the last 20 years on how simulation should be used optimally. Simulation is also more than a technology learning experience for supplanting the traditional approach of repeated practice. Research has shown that simulation works best when it is integrated into a curriculum. Learning is optimal when trainees receive metric-based feedback on their performance....
Source: The Ulster Medical Journal - September 1, 2012 Category: Journals (General) Authors: Gallagher AG Tags: Ulster Med J Source Type: research

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging
PET is a functional imaging method that can exploit various aspects of tumor biology to enable greater detection of prostate cancer than can be provided by morphologic imaging alone. Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic acid (18F-fluciclovine) is a nonnaturally occurring amino acid PET radiotracer that was recently approved by the U.S. Food and Drug Administration for detection of suspected recurrent prostate cancer. The tumor-imaging features of this radiotracer mirror the upregulation of transmembrane amino acid transport that occurs in prostate cancer because of increased amino acid metabolism for energy and...
Source: Journal of Nuclear Medicine - May 1, 2018 Category: Nuclear Medicine Authors: Parent, E. E., Schuster, D. M. Tags: Continuing Education Source Type: research

Systemic Radiopharmaceutical Therapy of Pheochromocytoma and Paraganglioma
Whereas benign pheochromocytomas and paragangliomas are often successfully cured by surgical resection, treatment of metastatic disease can be challenging in terms of both disease control and symptom control. Fortunately, several options are available, including chemotherapy, radiation therapy, and surgical debulking. Radiolabeled metaiodobenzylguanidine (MIBG) and somatostatin receptor imaging have laid the groundwork for use of these radiopharmaceuticals as theranostic agents. 131I-MIBG therapy of neuroendocrine tumors has a long history, and the recent approval of high-specific-activity 131I-MIBG for metastatic or inope...
Source: Journal of Nuclear Medicine - September 2, 2021 Category: Nuclear Medicine Authors: Carrasquillo, J. A., Chen, C. C., Jha, A., Pacak, K., Pryma, D. A., Lin, F. I. Tags: Continuing Education Source Type: research

A critical review two-years thereafter of the effectiveness of the revolutionary changes in a gastroenterology division at a medical school teaching hospital due to the COVID-19 pandemic: GI physician clinical practice and emotional stresses, GI graduate medical education, GI professional societies, and pandemic control
Critically review approximately two years afterwards the effectiveness of revolutionary changes at an academic gastroenterology division from COVID-19 pandemic surge at metropolitan Detroit epicenter from 0 infected patients on March 9, 2020, to>300 infected patients (one-quarter of) in-hospital census in April 2020 and>200 infected patients in April 2021.GI Division, William Beaumont Hospital which had 36 GI clinical faculty who used to perform>23,000 endoscopies annually with massive plunge in endoscopy volume during the past two years; fully accredited GI fellowship since 1973; employs>400 house staff annually since 199...
Source: Gastroenterology Clinics of North America - December 16, 2022 Category: Gastroenterology Authors: Mitchell S. Cappell Source Type: research

Updating professional development for medical librarians to improve our evidence-based medicine and information literacy instruction.
Authors: Costello J Abstract Medical librarians lack professional development opportunities in the critical appraisal of biomedical evidence. An update to our professional development opportunities could support our efforts to teach critical appraisal of biomedical evidence during evidence-based medicine or information literacy instruction. If we enhance our understanding of latent influences on evidence quality-such as changes to Food and Drug Administration regulations, predatory or deceptive publishing practices, and clinical trial study designs-we can improve our value to medical education and hospital systems....
Source: Journal of the Medical Library Association : JMLA - July 4, 2018 Category: Databases & Libraries Tags: J Med Libr Assoc Source Type: research

Protect Medical Devices From Cyber Attacks, FDA Urges
The FDA is urging medical device makers and health care facilities to make sure there are proper safeguards in place to protect their medical devices from cyber threats. The FDA (Food and Drug Administration) said on Thursday that its warning is directed specifically at biomedical engineers, health care IT and procurements staff, medical device user facilities, hospitals and medical device manufacturers. A cyber attack may be caused when *malware is introduced into medical equipment, as well as unauthorized people gaining access to configuration settings in hospital networks and equipment...
Source: Health News from Medical News Today - June 14, 2013 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

5 Nutrition Facts misconceptions that sabotage patient health
The fight against diabetes and heart disease also means fighting nutritional misunderstandings and offering sound advice to patients. A new video helps dispel common misconceptions about the Nutrition Facts label found on food packages and offers physicians guidance on how to educate their patients. Designed to help patients better understand what they are consuming and make more informed decisions about their daily diet, the Nutrition Facts label can be a powerful tool when used correctly. A new video from the AMA and the U.S. Food and Drug Administration (FDA) offers tips to get started using the label and describes ...
Source: AMA Wire - July 15, 2016 Category: Journals (General) Authors: Troy Parks Source Type: news

Cuba Has Made At Least 3 Major Medical Innovations That We Need
By most measures, the United States' business-friendly environment has proven to be fertile for medical innovation. Compared to other countries, America has filed the most patents in the life sciences, is conducting most of the world's clinical trials and has published the most biomedical research. That's what makes the medical prominence of Cuba all the more surprising to those who view a free market as an essential driver of scientific discovery. Cuba is very poor, and yet the country has some of the healthiest, most long-lived residents in the world -- as well as a medical invention or two that could run circl...
Source: Science - The Huffington Post - March 15, 2016 Category: Science Source Type: news

Discrepancies Between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on Immunization Practices Recommendations: Provider Knowledge and Attitudes.
The objectives of this study were: (1) to categorize differences between FDA vaccine licensure indications and ACIP/CDC vaccine recommendations for vaccines; and (2) to assess knowledge, attitudes, and practices of pediatricians, family physicians, and obstetrician-gynecologists regarding their understanding of differences. METHODS: Information was extracted from FDAvaccine package inserts, and corresponding information was collected for ACIP/CDC vaccine recommendations (2000-2014) for vaccines in the childhood and adult immunization schedules. Surveys regarding knowledge of discrepancies were distributed electronical...
Source: Clinical Therapeutics - August 11, 2018 Category: Drugs & Pharmacology Authors: Bell CE, Shane AL, Pickering LK Tags: Clin Ther Source Type: research

Chronic myelomonocytic leukemia: 2013 update on diagnosis, risk stratification, and management
Disease overviewChronic myelomonocytic leukemia (CMML) is a clonal hematopoietic stem cell disorder that is classified as a myelodysplastic/myeloproliferative neoplasm by the 2008 World Health Organization classification of hematopoietic tumors. It is characterized by absolute monocytosis (>1 × 109/L) in the peripheral blood that persists for at least 3 months. DiagnosisThe diagnosis of CMML rests on a combination of morphologic, histopathologic and chromosomal abnormalities in the bone marrow. It is important to exclude other myeloproliferative neoplasms and infectious/autoimmune conditions that can cause monocyto...
Source: American Journal of Hematology - October 24, 2013 Category: Hematology Authors: Sameer A. Parikh, Ayalew Tefferi Tags: Annual Clinical Updates in Hematological Malignancies: A Continuing Medical Education Series Source Type: research