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About 1,660 results

Regulatory Status of Cannabidiol in the United States: A Perspective
https://www.liebertpub.com/doi/full/10.1089/can.2018.0030
Cannabis and Cannabinoid Research; Corroon,J.,et al

Oct 18th, 2018 - Cannabidiol (CBD) is 1 of > 100 cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis). Despite its complex and rapidly evolving regulatory status in the United States, projected retail sales of CBD products—hemp, cannabis and pharmaceutical—are as high as $1.9 billion by 2020. CBD products can currently be purchased online, over the counter, and...

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents.
https://doi.org/10.1002/phar.1780
Pharmacotherapy Fasinu PS, Phillips S et. al.

Jun 11th, 2016 - States and the federal government are under growing pressure to legalize the use of cannabis products for medical purposes in the United States. Sixteen states have legalized (or decriminalized possession of) products high in cannabidiol (CBD) and with restricted ∆(9) -tetrahydrocannabinol (∆(9) -THC) content. In most of these states, the intent is for ...

Current legal status of medical marijuana and cannabidiol in the Unite...
https://doi.org/10.1016/j.yebeh.2020.107452
Epilepsy & Behavior : E&B; Alharbi YN

Sep 22nd, 2020 - In the United States, access to marijuana and its related products has been outlawed since passing the Controlled Substance Act (CSA) in 1970. Under this act, marijuana is classified as Schedule I substance and is considered to have a high potential for dependency and abuse as well as unaccepted medical use. From that time, multiple states have taken measures to legalize an...

Approval Status and Regulatory Actions for Radiopharmaceuticals in the
https://doi.org/10.1177/2168479014524406
Therapeutic Innovation & Regulatory Science; Hanamura N, Aruga A

Sep 1st, 2014 - The aim of this study was to identify the differences between Japan and the United States in the approval status and regulatory actions for radiopharmaceuticals. The package inserts of radiopharmaceuticals that have been approved in the United States and Japan were used to investigate the status of approval in each country, examining the similari...

Hospital neonatal services in the United States: variation in definitions...
https://doi.org/10.1038/jp.2009.148
Journal of Perinatology : Official Journal of the Califor... Blackmon LR, Barfield WD et. al.

Oct 9th, 2009 - The purpose of this study was to describe variation among states in designations of hospital neonatal services levels. We systematically searched all 50 states and District of Columbia governmental web sites and extracted definitions and levels terminology, functional and utilization criteria, regulatory compliance and funding measures, and citation of American Academy of Pediatrics (AAP) docum...

Evolution and current status of United States Food and Drug Admini...
https://doi.org/10.1097/MCC.0000000000000524
Current Opinion in Critical Care; Talbot GH

Aug 30th, 2018 - Regulatory guidance for design, conduct and analysis of studies of nosocomial pneumonia, including ventilator-associated pneumonia, has undergone substantial evolution over the past three decades. This review summarizes this evolutionary process and the current status of guidance. The US Food and Drug Administration and the European Medicines Agency have taken different approaches to defining e...

The Legal and Regulatory Status of Biosimilars: How Product Naming and St...
https://www.ncbi.nlm.nih.gov/pubmed/26237983
American Journal of Law & Medicine; Paradise J

Aug 5th, 2015 - Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for "biosimilar" a...

Domperidone for Lactation: What Health Care Providers Need to Know.
https://doi.org/10.1097/AOG.0000000000002033
Obstetrics and Gynecology; Sewell CA, Chang CY et. al.

May 10th, 2017 - This commentary serves to raise health care provider awareness about the regulatory status and available evidence regarding domperidone for insufficient lactation. Breastfeeding provides significant health benefits for mothers and infants, and insufficient milk production remains the most common reason for early weaning. Domperidone, a dopamine receptor antagonist that may increas...

Rheumatology patients seek guidance on CBD, cannabis products
https://www.mdedge.com/rheumatology/article/252214/pain/rheumatology-patients-seek-guidance-cbd-cannabis-products
Jeff Craven

Feb 25th, 2022 - Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium. While cannabis is still regulated as a Schedule I drug in the United States, CBD produ.

The road to commercialization in Africa: lessons from developing the sickle-cell drug N...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001608
BMC International Health and Human Rights; Perampaladas K, Masum H et. al.

Dec 15th, 2010 - Developing novel drugs from traditional medicinal knowledge can serve as a means to improve public health. Yet countries in sub-Saharan Africa face barriers in translating traditional medicinal knowledge into commercially viable health products. Barriers in moving along the road towards making a new drug available include insufficient manufacturing capacity; knowledge sharing between scientists...

Rheumatology Patients Seek Guidance on CBD, Cannabis Products
https://www.medscape.com/viewarticle/969200

Feb 25th, 2022 - Although there is a lack of evidence for use of cannabidiol (CBD) products and cannabis in rheumatology, many patients are using them anyway and want to discuss the use of these products with their rheumatologists, according to a speaker at the 2022 Rheumatology Winter Clinical Symposium. While cannabis is still regulated as a Schedule I drug in the United States, CBD produ...

Palmitoylethanolamide: A Potential Alternative to Cannabidiol.
https://doi.org/10.1080/19390211.2021.2005733
Journal of Dietary Supplements; Clayton P, Subah S et. al.

Nov 30th, 2021 - The endocannabinoid system (ECS) is a widespread cell signaling network that maintains homeostasis in response to endogenous and exogenous stressors. This has made the ECS an attractive therapeutic target for various disease states. The ECS is a well-known target of exogenous phytocannabinoids derived from cannabis plants, the most well characterized being Δ9-tetrahydrocannabinol (THC) and cann...

Psychotropic Drug Prescription in Children and Adolescents: Approved Medications in Eur...
https://doi.org/10.1089/cap.2021.0027
Journal of Child and Adolescent Psychopharmacology; Smogur M, Onesanu A et. al.

Feb 10th, 2022 - Objectives: The decision to prescribe a medication and the choice of which one are often complex, particularly in the field of child and adolescent psychiatry where evidence is scarce. The aim of this review is to provide a synthesis of psychotropic drugs approved in children and adolescents for psychiatric indications in several countries. Methods: All psychopharmacological treatments used in ...

Belumosudil with ROCK-2 inhibition: chemical and therapeutic development to FDA approva...
https://doi.org/10.1016/j.retram.2022.103343
Current Research in Translational Medicine; Ali F, Ilyas A

Mar 27th, 2022 - Belumosudil (BLM) is a ROCK inhibitor that has been firstly developed by Surface Logix, later acquired by Kadmon Pharmaceuticals for the treatment of chronic graft-versus-host disease (cGVHD), Psoriasis Vulgaris (PV), idiopathic pulmonary fibrosis (IPF), hepatic impairment (HI), diffuse cutaneous systemic sclerosis (dcSSc). BLM received a breakthrough therapy designation and priority review fro...

Development of cannabidiol as a treatment for severe childhood epilepsies.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707087
British Journal of Pharmacology; Williams CM, Stephens GJ

Sep 29th, 2020 - In recent years, there has been a growing appreciation by regulatory authorities that cannabis-based medicines can play a useful role in disease therapy. Although often conflagrated by proponents of recreational use, the legislative rescheduling of cannabis-derived compounds, such as cannabidiol (CBD), has been associated with the steady increase in the pursuit of use of medicinal cannabis. One...

Endocannabinoid system and cannabis hyperemesis syndrome: a narrative update.
https://doi.org/10.1097/MEG.0000000000001992
European Journal of Gastroenterology & Hepatology; Perisetti A, Goyal H

Nov 20th, 2020 - Cannabis use has been increasing in the United States and throughout the world. It is derived from one of the earliest plants cultivated by humans - Cannabis sativa. Cannabis (also called marijuana) is the most commonly used psychoactive substance worldwide. The cannabis plant has more than 400 chemicals, of which more than 100 cannabinoids (such as cannabigerol, cannabidiol, and ...

Convergence of case-specific epigenetic alterations identify a confluence of genetic vu...
https://doi.org/10.1038/s41380-022-01477-y 10.1126/science.1222794
Molecular Psychiatry; Corradin O, Sallari R et. al.

Mar 19th, 2022 - Opioid use disorder is a highly heterogeneous disease driven by a variety of genetic and environmental risk factors which have yet to be fully elucidated. Opioid overdose, the most severe outcome of opioid use disorder, remains the leading cause of accidental death in the United States. We interrogated the effects of opioid overdose on the brain using ChIP-seq to quantify patterns...

FDA, Researchers Still in the Weeds on Cannabis, CBD, and Gender
https://www.medscape.com/viewarticle/941927

Dec 2nd, 2020 - The acceptance of medical marijuana and cannabidiol (CBD) products is picking up momentum across the United States. Case in point, last month an additional five states voted to legalize medicinal or recreational cannabis, putting more pressure on the medical, research, and regulatory communities to provide some guidance. The US Food and Drug Administration (FD...

Considerations from the College of American Pathologists for Implementation of an Assay...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451421
Journal of Clinical Microbiology; Peaper DR, Rhoads DD et. al.

Jul 15th, 2021 - The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers' in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2. The U.S. government's Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulates the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has autho...

A feasibility study to assess social stress and social support in patients enrolled in ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8960472
Epilepsy & Behavior : E&B; McCann ZH, Szaflarski M et. al.

Oct 3rd, 2021 - Cannabidiol (CBD) trials offer an opportunity to examine social factors that shape outcomes of patients with treatment-resistant epilepsy. Prior research of patients treated with CBD for epilepsy describes financial struggles of these patients/families and the association between socioeconomic status and patient-centered outcomes. However, social determinants of health in this pop...