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Management: Food and Drug Administration (FDA)
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Total 7481 results found since Jan 2013.
Suppression of NLRP3 inflammasome by ivermectin ameliorates bleomycin-induced pulmonary fibrosis
This study aimed to explore the ability of ivermectin (0.6 mg/kg) to alleviate bleomycin-induced biochemical derangements and histological changes in an experimental PF rat model. This can provide the means to validate the clinical utility of ivermectin as a treatment option for idiopathic PF. The results showed that ivermectin mitigated the bleomycin-evoked pulmonary injury, as manifested by the reduced infiltration of inflammatory cells, as well as decreased the inflammation and fibrosis scores. Intriguingly, ivermectin decreased collagen fiber deposition and suppressed transforming growth factor-β1 (TGF-β1) and ...
Source: J Zhejiang Univ Sci ... - August 8, 2023 Category: Science Authors: Mai A Abd-Elmawla Heba R Ghaiad Enas S Gad Kawkab A Ahmed Maha Abdelmonem Source Type: research
ACMT Position Statement: Position on the Recent Judicial Challenge of U.S. Food and Drug Administration Approval of Mifepristone
J Med Toxicol. 2023 Aug 7. doi: 10.1007/s13181-023-00960-4. Online ahead of print.NO ABSTRACTPMID:37548894 | DOI:10.1007/s13181-023-00960-4
Source: Journal of Medical Toxicology - August 7, 2023 Category: Toxicology Authors: Maryann Mazer-Amirshahi Andrew I Stolbach Peggy Ye Source Type: research
Use of real-world evidence in neuroscience-related new drug and biologics license applications for novel therapeutics
Clin Pharmacol Ther. 2023 Aug 7. doi: 10.1002/cpt.3018. Online ahead of print.ABSTRACTThe US Food and Drug Administration (FDA) is evaluating the potential use of real-world evidence (RWE) in regulatory decision-making. Some groups have evaluated the use of RWE in regulatory submissions in the United States and abroad, reporting that reliance on RWE to support new product approvals is relatively common. Confusion regarding the use of RWE in drug-approval decisions may arise, however, based on different application of the terms real-world data (RWD) and RWE. We evaluated RWE in NDAs and BLAs from January 2019 to June 2021 f...
Source: Clinical Pharmacology and Therapeutics - August 7, 2023 Category: Drugs & Pharmacology Authors: Bartholt Bloomfield-Clagett Motiur Rahman Kimberly Smith John Concato Source Type: research
Use of ICS and Fast-Acting Bronchodilators in Asthma: Past, Present, and Future
J Fam Pract. 2023 Jul;72(6 Suppl):S61-S70. doi: 10.12788/jfp.0625.ABSTRACTPrimary care practitioners (PCPs) play a key role in asthma management since most patients with asthma are treated in primary care settings. Despite continual advances in asthma care, important practice gaps remain, and the high burden of asthma exacerbations persists, with 43% of children with asthma and 41% of adults with asthma in the United States experiencing an asthma exacerbation in 2020. Uncontrolled asthma, incomplete assessment of exacerbation and asthma control history, reliance on systemic corticosteroids (SCS) or short-acting beta2-agoni...
Source: The Journal of Family Practice - August 7, 2023 Category: Practice Management Authors: Neil Skolnik Marissa Norden Njira Lugogo Wendy Wright Source Type: research
ACMT Position Statement: Position on the Recent Judicial Challenge of U.S. Food and Drug Administration Approval of Mifepristone
J Med Toxicol. 2023 Aug 7. doi: 10.1007/s13181-023-00960-4. Online ahead of print.NO ABSTRACTPMID:37548894 | DOI:10.1007/s13181-023-00960-4
Source: Journal of Medical Toxicology - August 7, 2023 Category: Toxicology Authors: Maryann Mazer-Amirshahi Andrew I Stolbach Peggy Ye Source Type: research
Use of ICS and Fast-Acting Bronchodilators in Asthma: Past, Present, and Future
J Fam Pract. 2023 Jul;72(6 Suppl):S61-S70. doi: 10.12788/jfp.0625.ABSTRACTPrimary care practitioners (PCPs) play a key role in asthma management since most patients with asthma are treated in primary care settings. Despite continual advances in asthma care, important practice gaps remain, and the high burden of asthma exacerbations persists, with 43% of children with asthma and 41% of adults with asthma in the United States experiencing an asthma exacerbation in 2020. Uncontrolled asthma, incomplete assessment of exacerbation and asthma control history, reliance on systemic corticosteroids (SCS) or short-acting beta2-agoni...
Source: The Journal of Family Practice - August 7, 2023 Category: Practice Management Authors: Neil Skolnik Marissa Norden Njira Lugogo Wendy Wright Source Type: research
Insomnia Management: A Review and Update
J Fam Pract. 2023 Jul;72(6 Suppl):S31-S36. doi: 10.12788/jfp.0620.ABSTRACTInsomnia is a distinct disorder that is common, yet underrecognized and undertreated in primary care. Treating insomnia has been shown to improve outcomes, including reduced risk of developing cardiovascular and mental health disorders. Insomnia is influenced by the brain's regulation of sleep and wake, which are mutually exclusive events. Insomnia should be treated as a distinct condition, even when occurring with a comorbid diagnosis such as depression or anxiety. Clinicians should implement a multimodal approach to insomnia management, including n...
Source: The Journal of Family Practice - August 7, 2023 Category: Practice Management Authors: David P Shaha Source Type: research
Use of ICS and Fast-Acting Bronchodilators in Asthma: Past, Present, and Future
J Fam Pract. 2023 Jul;72(6 Suppl):S61-S70. doi: 10.12788/jfp.0625.ABSTRACTPrimary care practitioners (PCPs) play a key role in asthma management since most patients with asthma are treated in primary care settings. Despite continual advances in asthma care, important practice gaps remain, and the high burden of asthma exacerbations persists, with 43% of children with asthma and 41% of adults with asthma in the United States experiencing an asthma exacerbation in 2020. Uncontrolled asthma, incomplete assessment of exacerbation and asthma control history, reliance on systemic corticosteroids (SCS) or short-acting beta2-agoni...
Source: The Journal of Family Practice - August 7, 2023 Category: Practice Management Authors: Neil Skolnik Marissa Norden Njira Lugogo Wendy Wright Source Type: research
Insomnia Management: A Review and Update
J Fam Pract. 2023 Jul;72(6 Suppl):S31-S36. doi: 10.12788/jfp.0620.ABSTRACTInsomnia is a distinct disorder that is common, yet underrecognized and undertreated in primary care. Treating insomnia has been shown to improve outcomes, including reduced risk of developing cardiovascular and mental health disorders. Insomnia is influenced by the brain's regulation of sleep and wake, which are mutually exclusive events. Insomnia should be treated as a distinct condition, even when occurring with a comorbid diagnosis such as depression or anxiety. Clinicians should implement a multimodal approach to insomnia management, including n...
Source: The Journal of Family Practice - August 7, 2023 Category: Practice Management Authors: David P Shaha Source Type: research
