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Total 7304 results found since Jan 2013.
A New Hope in Alzheimer's Disease Psychosis: Pimavanserin
Curr Alzheimer Res. 2023 Aug 25. doi: 10.2174/1567205020666230825124922. Online ahead of print.ABSTRACTAlzheimer's disease (AD) ranks first among the causes of dementia worldwide. AD can develop a psychotic manifest at a significant rate. AD prognosis worsens by added psychosis clinic. There is no treatment approved by the United States Food and Drug Administration (FDA) among antipsychotics for Alzheimer's disease Psychosis (ADP). However, pimavanserine, an atypical antipsychotic, has been approved by the FDA for Parkinson's psychosis. It is predicted that pimavanserin, a new antipsychotic, will fill an important gap in t...
Source: Current Alzheimer Research - August 29, 2023 Category: Neurology Authors: Faruk Kurhan Mustafa Ak ın Source Type: research
Reassessment of the cadmium toxicological reference value for use in human health assessments of foods
Regul Toxicol Pharmacol. 2023 Aug 26;144:105487. doi: 10.1016/j.yrtph.2023.105487. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) developed an oral toxicological reference value (TRV) for characterizing potential health concerns from dietary exposure to cadmium (Cd). The development of the TRV leveraged the FDA's previously published research including (1) a systematic review for adverse health effects associated with oral Cd exposure and (2) a human physiological based pharmacokinetic (PBPK) model adapted from Kjellstrom and Nordberg (1978) for use in reverse dosimetry applied to the U.S. popula...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Heather R Schaefer Brenna M Flannery Lynn M Crosby R égis Pouillot Sofia M Santillana Farakos Jane M Van Doren Sherri Dennis Suzanne Fitzpatrick Karlyn Middleton Source Type: research
Bleeding Complications in Vancomycin-Induced Thrombocytopenia: A Real-World Postmarketing Pharmacovigilance Analysis
The objective of this study is to assess the potential relevance between vancomycin and bleeding complications in thrombocytopenia.METHODS: This is a real-world pharmacovigilance study conducted in October 2022 using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a disproportional analysis to assess the risk of bleeding complications in vancomycin-induced thrombocytopenia by calculating reporting odds ratios (RORs) and information components (ICs), with a weak signal defined as a lower limit of the IC 95% CI of 0 to 1.5, a middle signal defined as a lower limit of the IC 9...
Source: Clinical Therapeutics - August 28, 2023 Category: Drugs & Pharmacology Authors: Hui Yang Ying Zhang Xin Feng Zhuoling An Source Type: research
Reassessment of the cadmium toxicological reference value for use in human health assessments of foods
Regul Toxicol Pharmacol. 2023 Aug 26:105487. doi: 10.1016/j.yrtph.2023.105487. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) developed an oral toxicological reference value (TRV) for characterizing potential health concerns from dietary exposure to cadmium (Cd). The development of the TRV leveraged the FDA's previously published research including (1) a systematic review for adverse health effects associated with oral Cd exposure and (2) a human physiological based pharmacokinetic (PBPK) model adapted from Kjellstrom and Nordberg (1978) for use in reverse dosimetry applied to the U.S. population...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Heather R Schaefer Brenna M Flannery Lynn M Crosby R égis Pouillot Sofia M Santillana Farakos Jane M Van Doren Sherri Dennis Suzanne Fitzpatrick Karlyn Middleton Source Type: research
Bleeding Complications in Vancomycin-Induced Thrombocytopenia: A Real-World Postmarketing Pharmacovigilance Analysis
The objective of this study is to assess the potential relevance between vancomycin and bleeding complications in thrombocytopenia.METHODS: This is a real-world pharmacovigilance study conducted in October 2022 using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a disproportional analysis to assess the risk of bleeding complications in vancomycin-induced thrombocytopenia by calculating reporting odds ratios (RORs) and information components (ICs), with a weak signal defined as a lower limit of the IC 95% CI of 0 to 1.5, a middle signal defined as a lower limit of the IC 9...
Source: Clinical Therapeutics - August 28, 2023 Category: Drugs & Pharmacology Authors: Hui Yang Ying Zhang Xin Feng Zhuoling An Source Type: research
Reassessment of the cadmium toxicological reference value for use in human health assessments of foods
Regul Toxicol Pharmacol. 2023 Aug 26:105487. doi: 10.1016/j.yrtph.2023.105487. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) developed an oral toxicological reference value (TRV) for characterizing potential health concerns from dietary exposure to cadmium (Cd). The development of the TRV leveraged the FDA's previously published research including (1) a systematic review for adverse health effects associated with oral Cd exposure and (2) a human physiological based pharmacokinetic (PBPK) model adapted from Kjellstrom and Nordberg (1978) for use in reverse dosimetry applied to the U.S. population...
Source: Regulatory Toxicology and Pharmacology : RTP - August 28, 2023 Category: Toxicology Authors: Heather R Schaefer Brenna M Flannery Lynn M Crosby R égis Pouillot Sofia M Santillana Farakos Jane M Van Doren Sherri Dennis Suzanne Fitzpatrick Karlyn Middleton Source Type: research
New Non-Steroidal Topical Therapies for Inflammatory Dermatoses-Part 2: Tapinarof
Skinmed. 2023 Aug 28;21(3):177-181. eCollection 2023.ABSTRACTSince its introduction in 1952, topical glucocorticosteroids remain the initial and long-term treatment option for various forms of inflammatory dermatitis. A number of non-steroidal topicals for treating inflammatory dermatoses have been developed in the recent decades (such as topical calcineurin inhibitors, vitamin D analogues, and phophodiesterase-4 inhibitors), but none had the combination of broad therapeutic range, relatively rapid onset of action, high tolerability, and wide-spread clinical success; this allowed topical glucocorticosteroids to remain the ...
Source: Skinmed - August 27, 2023 Category: Dermatology Authors: Margaret DiRuggiero Elizabeth Mancuso-Stewart Douglas DiRuggiero Matt Zirwas Source Type: research
Investigation of immunogenicity assessment of biosimilar monoclonal antibodies in the United States
Clin Pharmacol Ther. 2023 Aug 27. doi: 10.1002/cpt.3033. Online ahead of print.ABSTRACTImmunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. We aimed to investigate the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research, United States Food and Drug Administration (USFDA) as of March 13, 2022, co...
Source: Clinical Pharmacology and Therapeutics - August 27, 2023 Category: Drugs & Pharmacology Authors: Ching-An Cheng Ai-Lei Jiang Yu-Ru Liu Lin-Chau Chang Source Type: research
New Non-Steroidal Topical Therapies for Inflammatory Dermatoses-Part 2: Tapinarof
Skinmed. 2023 Aug 28;21(3):177-181. eCollection 2023.ABSTRACTSince its introduction in 1952, topical glucocorticosteroids remain the initial and long-term treatment option for various forms of inflammatory dermatitis. A number of non-steroidal topicals for treating inflammatory dermatoses have been developed in the recent decades (such as topical calcineurin inhibitors, vitamin D analogues, and phophodiesterase-4 inhibitors), but none had the combination of broad therapeutic range, relatively rapid onset of action, high tolerability, and wide-spread clinical success; this allowed topical glucocorticosteroids to remain the ...
Source: Skinmed - August 27, 2023 Category: Dermatology Authors: Margaret DiRuggiero Elizabeth Mancuso-Stewart Douglas DiRuggiero Matt Zirwas Source Type: research
Investigation of immunogenicity assessment of biosimilar monoclonal antibodies in the United States
Clin Pharmacol Ther. 2023 Aug 27. doi: 10.1002/cpt.3033. Online ahead of print.ABSTRACTImmunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. We aimed to investigate the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research, United States Food and Drug Administration (USFDA) as of March 13, 2022, co...
Source: Clinical Pharmacology and Therapeutics - August 27, 2023 Category: Drugs & Pharmacology Authors: Ching-An Cheng Ai-Lei Jiang Yu-Ru Liu Lin-Chau Chang Source Type: research
