Supplemental Calcium and Risk Reduction of Hypertension, Pregnancy-Induced Hypertension, and Preeclampsia: An Evidence-Based Review by the US Food and Drug Administration

2008 ◽  
Vol 65 (2) ◽  
pp. 78-87 ◽  
Author(s):  
Paula R. Trumbo ◽  
Kathleen C. Ellwood
Keyword(s):  
Risk Reduction ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Evidence Based ◽  
Pregnancy Induced Hypertension ◽  
Supplemental Calcium ◽  
The Us ◽  
Induced Hypertension

Primer on Depression

Depression ◽  
2019 ◽  
pp. 197-217
Author(s):  
Naji C. Salloum ◽  
George I. Papakostas
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Augmentation Strategies ◽  
Investigational Drugs ◽  
The Us ◽  
Initial Medication

Several first-line antidepressant therapies are currently available for the treatment of major depressive disorder (MDD), but in most patients depression fail to remits after an initial medication trial. In this chapter, we explore the evidence for different augmentation strategies used to enhance the response from an initial antidepressant monotherapy. Atypical antipsychotics, several of which are now approved by the US Food and Drug Administration as adjunctive agents for the treatment of MDD, and lithium are among the most evidence-based augmentation pharmacotherapies. Other therapies, such as bupropion, mirtazapine, triiodothyronine, nutraceuticals, and psychotherapy, are also commonly used. Additionally, several investigational drugs, including ketamine, esketamine, and ALKS 5461, with novel mechanisms of action, show promise.

Psyllium husk intake and risk of type 2 diabetes: an evidence-based scientific and regulatory review of a qualified health claim conducted by the US Food and Drug Administration

2020 ◽  
Vol 78 (10) ◽  
pp. 787-797
Author(s):  
Crystal R Rivers ◽  
Mark A Kantor
Keyword(s):  
Type 2 Diabetes ◽  
Drug Administration ◽  
Scientific Evidence ◽  
Food And Drug Administration ◽  
Evidence Based ◽  
Health Claim ◽  
Regulatory Review ◽  
Psyllium Husk ◽  
The Us

Abstract The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA’s review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA’s enforcement discretion letter for this qualified health claim stated: “Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.”

scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

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