Filtered By:
Condition: Pregnancy
Management: Food and Drug Administration (FDA)
This page shows you your search results in order of date.
Order by Relevance | Date
Total 372 results found since Jan 2013.
Psychopharmacotherapy during pregnancy and breastfeeding-Part I: focus on pregnancy : Support options by using therapeutic drug monitoring
Nervenarzt. 2023 Jul 17. doi: 10.1007/s00115-023-01528-x. Online ahead of print.ABSTRACTThe medicinal treatment of mental disorders during pregnancy and lactation requires special knowledge about possible effects of the psychopharmacotherapy on the intrauterine exposure of the embryo/fetus. Therefore, the first part of this 2‑part article focuses on the use of psychotropic drugs during pregnancy. In the second part, the use of psychotropic drugs during breastfeeding is addressed. Possible substance-specific risks as a consequence of the administration have to be assessed compared to the natural risk of pregnancy complica...
Source: Der Nervenarzt - July 17, 2023 Category: Neurology Authors: Michael Paulzen Georgios Schoretsanitis Source Type: research
Six Years of FDA's Postmarket Active Risk Identification and Analysis System (ARIA) in the Sentinel Initiative: Implications for Real World Evidence Generation
We report on the first six years of ARIA utilization in the Sentinel System (2016 -2021). The FDA has used the ARIA system to evaluate 133 safety concerns; 54 of these evaluations have closed with regulatory determinations while the rest remain in progress. If the ARIA system and FDA's Adverse Event Reporting System are deemed insufficient to address a safety concern, then FDA may issue a postmarket requirement to a product's manufacturer. One-hundred-ninety-seven ARIA insufficiency determinations have been made. The most common situation for which ARIA was found to be insufficient is the evaluation of adverse pregnancy an...
Source: Clinical Pharmacology and Therapeutics - June 30, 2023 Category: Drugs & Pharmacology Authors: Judith C Maro Michael D Nguyen Joy Kolonoski Ryan Schoeplein Ting-Ying Huang Sarah K Dutcher Gerald J Dal Pan Robert Ball Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.ABSTRACTAs pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Adm...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Daphne Guinn Leyla Sahin Elimika Pfuma Fletcher Su-Young Choi Tamara Johnson Miriam Dinatale Kristie Baisden Wenjie Sun Venkateswaran C Pillai Jose Pablo Morales Lynne Yao Source Type: research
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S159-S169. doi: 10.1002/jcph.2251.ABSTRACTThe availability of clinical pharmacology and safety data regarding the use of prescription medications in pregnant and lactating individuals has been historically limited, despite significant efforts to improve the quantity and quality of the information in labeling. The Food and Drug Administration's (FDA) Pregnancy and Lactation Labeling Rule took effect on June 30, 2015, and updated information in labeling to more clearly describe available data to assist health care providers in counseling pregnant and lactating individuals. Additionally, ...
Source: The Journal of Clinical Pharmacology - June 15, 2023 Category: Drugs & Pharmacology Authors: Srikanth C Nallani Kristie Baisden Miriam Dinatale Lisa Basham Deep Kwatra Lynne Yao Source Type: research
