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Management: Food and Drug Administration (FDA)

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Total 7385 results found since Jan 2013.

United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism
Expert Opin Drug Saf. 2023 Aug 18:1-6. doi: 10.1080/14740338.2023.2245748. Online ahead of print.ABSTRACTINTRODUCTION: Nuclear reactor incidents and bioterrorism outbreaks are concerning public health disasters. Little is known about US Food and Drug Administration (FDA)-approved agents that can mitigate consequences of these events. We review FDA data supporting regulatory approvals of these agents.AREAS COVERED: We reviewed pharmaceutical products approved to treat Hematopoietic Acute Radiation Syndrome (H-ARS) and to treat or prevent pulmonary infections following Bacillus anthracis (anthrax) exposure. Four drugs were a...
Source: Expert Opinion on Drug Safety - August 18, 2023 Category: Drugs & Pharmacology Authors: Charles L Bennett Peter Georgantopoulos Robert Peter Gale Kevin Knopf William J Hrushesky Chadi Nabhan James O Armitage Source Type: research

Unexpected sirolimus-stimulated airway hyperreactivity in lymphangioleiomyomatosis
ERJ Open Res. 2023 Aug 14;9(4):00305-2023. doi: 10.1183/23120541.00305-2023. eCollection 2023 Jul.ABSTRACTLymphangioleiomyomatosis (LAM) is a multisystem disease affecting primarily women, characterised in the lung by proliferation of LAM cells, abnormal smooth muscle-like cells with dysfunctional tuberous sclerosis complex genes. This dysfunction results in activation of mechanistic target of rapamycin (mTOR), leading to LAM cell proliferation. Sirolimus (rapamycin) is the only United States Food and Drug Administration-approved treatment for pulmonary LAM, resulting in decreased LAM cell growth/size and stabilised lung f...
Source: Cell Research - August 17, 2023 Category: Cytology Authors: Wendy K Steagall Mario Stylianou Gustavo Pacheco-Rodriguez Zu Xi Yu Joel Moss Source Type: research

An assessment of older adults' selection of over ‐the‐counter medication: What information are they utilizing during the selection process?
While the study design assumed a deliberative decision-making process where adults would rely to a great degree on the Drug Facts Label (DFL) and written information from the packaging and labelling, what emerged was a habit-based decision-making process. Cues that participants reported from packaging and labelling were primarily simple heuristics, like colour and trade dress, used to identify products that had been previously used, facilitate cross-product comparisons or identify equivalent products. AbstractHerein, we investigate the information older adults use when selecting over-the-counter (OTC) medications. Two spec...
Source: Packaging Technology and Science - August 17, 2023 Category: Food Science Authors: Alyssa Harben, Shiva Esfahanian, Laura Bix Tags: RESEARCH ARTICLE Source Type: research

LC-MS/MS Investigation of Nitrosamine Impurities in Certain Sartan Group Medicinal Products Available in Istanbul, T ürkiye
Ann Pharm Fr. 2023 Aug 9:S0003-4509(23)00079-2. doi: 10.1016/j.pharma.2023.08.002. Online ahead of print.ABSTRACTNitrosamines (NAs) are molecules that include the nitroso functional group. In 2018, the US Food and Drug Administration (FDA) received its first report of NAs in pharmaceuticals. The fact that NA impurities are likely human carcinogens is relevant to these compounds. Furthermore, prolonged exposure to NA contaminants above safe limits may raise the risk of cancer. The goal of this article was to assess the amounts of six different NAs in sartan group medicines purchased from formal pharmacies in Istanbul, Türk...
Source: Annales Pharmaceutiques Francaises - August 11, 2023 Category: Drugs & Pharmacology Authors: Tuna Öncü Bayram Y üksel Emrullah Binay Nilg ün Şen Source Type: research

Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID-19 Testing Status Among Adults - United States, December 2020-March 2023
This report includes analysis of data on self-reported symptoms collected from 1,296 adults with COVID-like illness who were tested for SARS-CoV-2 using a Food and Drug Administration-approved polymerase chain reaction or antigen test at the time of enrollment and reported symptoms at 3-month intervals for 12 months. Prevalence of any symptom decreased substantially between baseline and the 3-month follow-up, from 98.4% to 48.2% for persons who received a positive SARS-CoV-2 test results (COVID test-positive participants) and from 88.2% to 36.6% for persons who received negative SARS-CoV-2 test results (COVID test-negative...
Source: MMWR Morb Mortal Wkl... - August 10, 2023 Category: Epidemiology Authors: Juan Carlos C Montoy James Ford Huihui Yu Michael Gottlieb Dana Morse Michelle Santangelo Kelli N O'Laughlin Kevin Schaeffer Pamela Logan Kristin Rising Mandy J Hill Lauren E Wisk Wafah Salah Ahamed H Idris Ryan M Huebinger Erica S Spatz Robert M Rodrigue Source Type: research

Viscoelastic testing: Critical appraisal of new methodologies and current literature
Int J Lab Hematol. 2023 Aug 9. doi: 10.1111/ijlh.14144. Online ahead of print.ABSTRACTUnited States Food and Drug Administration (FDA)-approved viscoelastic testing (VET) methodologies have significantly changed in the last 10 years, with the availability of cartridge-based VET. Some of these cartridge-based methodologies use harmonic resonance-based clot detection. While VET has always allowed for the evaluation of real-time clot formation, cartridge-based VET provides increased ease of use as well as greater portability and robustness of results in out-of-laboratory environments. Here we review the use of VET in a variet...
Source: International Journal of Laboratory Hematology - August 10, 2023 Category: Hematology Authors: Geoffrey D Wool Timothy Carll Source Type: research

Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID-19 Testing Status Among Adults - United States, December 2020-March 2023
This report includes analysis of data on self-reported symptoms collected from 1,296 adults with COVID-like illness who were tested for SARS-CoV-2 using a Food and Drug Administration-approved polymerase chain reaction or antigen test at the time of enrollment and reported symptoms at 3-month intervals for 12 months. Prevalence of any symptom decreased substantially between baseline and the 3-month follow-up, from 98.4% to 48.2% for persons who received a positive SARS-CoV-2 test results (COVID test-positive participants) and from 88.2% to 36.6% for persons who received negative SARS-CoV-2 test results (COVID test-negative...
Source: MMWR Morb Mortal Wkl... - August 10, 2023 Category: Epidemiology Authors: Juan Carlos C Montoy James Ford Huihui Yu Michael Gottlieb Dana Morse Michelle Santangelo Kelli N O'Laughlin Kevin Schaeffer Pamela Logan Kristin Rising Mandy J Hill Lauren E Wisk Wafah Salah Ahamed H Idris Ryan M Huebinger Erica S Spatz Robert M Rodrigue Source Type: research

Viscoelastic testing: Critical appraisal of new methodologies and current literature
Int J Lab Hematol. 2023 Aug 9. doi: 10.1111/ijlh.14144. Online ahead of print.ABSTRACTUnited States Food and Drug Administration (FDA)-approved viscoelastic testing (VET) methodologies have significantly changed in the last 10 years, with the availability of cartridge-based VET. Some of these cartridge-based methodologies use harmonic resonance-based clot detection. While VET has always allowed for the evaluation of real-time clot formation, cartridge-based VET provides increased ease of use as well as greater portability and robustness of results in out-of-laboratory environments. Here we review the use of VET in a variet...
Source: International Journal of Laboratory Hematology - August 10, 2023 Category: Hematology Authors: Geoffrey D Wool Timothy Carll Source Type: research