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About 82 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 17th, 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 Therapeu...
https://doi.org/10.1002/phar.1780
Pharmacotherapy Fasinu PS, Phillips S et. al.

Jun 10th, 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 ...

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 29th, 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...

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 4th, 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...

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and ...
https://doi.org/10.1055/s-0039-1692208
Homeopathy : the Journal of the Faculty of Homeopathy; Valavan R, Cesar A

Jul 29th, 2019 - Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a...

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

Aug 31st, 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 California Perinatal Association; Blackmon LR, Barfield WD et. al.

Oct 8th, 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 P...

The legal status of cannabis (marijuana) and cannabidiol (CBD) under U.S....
https://doi.org/10.1016/j.yebeh.2016.11.021
Epilepsy & Behavior : E&B; Mead A

Feb 8th, 2017 - In the United States, federal and state laws regarding the medical use of cannabis and cannabinoids are in conflict and have led to confusion among patients, caregivers, and healthcare providers. Currently, cannabis is legal for medical purposes in 50% of the states, and another seventeen states allow products that are high in cannabidiol (CBD) and low in THC ...

Hospital Neonatal Services in the United States: Variation in Definitions, Criteria, and Regulatory Status, 2008
https://www.medscape.com/viewarticle/717159

Abstract and Introduction Abstract Objective: The purpose of this study was to describe variation among states in designations of hospital neonatal services levels. Study Design: 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...

The Current Status of Sakigake Designation in Japan, PRIME in the European Union...
https://doi.org/10.1177/2168479016662682
Therapeutic Innovation & Regulatory Science; Kondo H, Hata T et. al.

Dec 31st, 2016 - Following the Breakthrough Therapy Designation system in 2012 in the United States, the Sakigake Designation was introduced in 2015 in Japan, and PRIME (PRIority MEdicines) was started in 2016 in the European Union. Each system aims at giving patients better access to innovative drugs and regenerative medicine products by providing product developers with generous regulatory...

Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncolog...
https://doi.org/10.1177/2168479019874062
Therapeutic Innovation & Regulatory Science; Muensterman ET, Luo Y et. al.

Sep 25th, 2019 - Because of the increasing demand for drugs addressing life-threatening and rare diseases, regulatory agencies have developed a variety of accelerated regulatory pathways. These programs are aimed at prioritizing the most promising drug candidates for diseases lacking satisfactory treatments. The most prominent accelerated programs introduced have been Breakthrough-Therapy Designat...

Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Re...
https://doi.org/10.1016/j.clinthera.2015.02.024
Clinical Therapeutics; Tsukamoto K

Mar 24th, 2015 - The incidence of Alzheimer's disease (AD) has been steadily increasing worldwide. AD is a serious disease that has both societal and economic impacts. The greatest risk factor for AD is aging. Thus, because of the rapidly aging population in Japan, the development of new, effective drugs for AD is urgently needed. The goal of the present article was to analyze the status, clarify the pro...

Comparative study of feminine hygiene product regulations in Korea, the European Union,...
https://doi.org/10.1016/j.yrtph.2019.05.022
Regulatory Toxicology and Pharmacology : RTP; Kwak JI, Nam SH et. al.

Jun 3rd, 2019 - Recently, Korean consumers have experienced public health issues as a result of problematic feminine hygiene products. Consumers and local civic groups have urged manufacturers and the Korean government to provide clear information based on comprehensive studies and strengthen related policies. In this study, we collected and compiled information on the relevant regulations and organizations in...

Hemophilia B Gene Therapy Receives Orphan Status in United States
https://www.medscape.com/viewarticle/756452

Jan 4th, 2012 - January 5, 2012 — A promising gene therapy for hemophilia B that received orphan designation in the European Union in November 2011 received the same status from the US Food and Drug Administration on January 4, 2012, as reported in a press release by Amsterdam Molecular Therapeutics (AMT), a leader in the field of human gene therapy. Orphan disease status applies to conditions th...

Industry Perspective of Pediatric Drug Development in the United States: ...
https://doi.org/10.1177/2168479017716718
Therapeutic Innovation & Regulatory Science; Onishi T, Tsukamoto K et. al.

May 1st, 2018 - Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European ...

Social status alters chromatin accessibility and the gene regulatory resp...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6347725
Proceedings of the National Academy of Sciences of the United States of America; Snyder-Mackler N, Sanz J et. al.

Dec 12th, 2018 - Low social status is an important predictor of disease susceptibility and mortality risk in humans and other social mammals. These effects are thought to stem in part from dysregulation of the glucocorticoid (GC)-mediated stress response. However, the molecular mechanisms that connect low social status and GC dysregulation to downstream health outcomes remain elusive. Here, we use...

Challenges in the Development of Drug/Device and Biologic/Device Combination Products i...
https://doi.org/10.1177/2168479014553033
Therapeutic Innovation & Regulatory Science; Tsourounis M, Stuart J et. al.

Feb 28th, 2015 - Compared with single-entity treatments, multientity or combination products have the potential to provide enhanced therapeutic utility. Because they involve components that would normally be overseen by different branches of health authorities (eg, different FDA centers), they raise numerous scientific, regulatory, policy, and review management challenges. This article summarizes the cur...

Probiotic foods and drugs: impact of US regulatory status on design of cl...
https://doi.org/10.1086/523321
Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America; Hibberd PL, Davidson L

Jan 9th, 2008 - Probiotics have been in widespread use since ancient times and are increasingly being consumed to maintain health and to prevent and treat a wide range of conditions. In the United States, probiotics are considered to be foods or biologics, depending on their intended use. This article addresses the similarities and differences between approaches to conducting clinical trials of p...

Vape Club: Exploring Non-Profit Regulatory Models for the Supply of Vaporised Ni...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6121462
International Journal of Environmental Research and Public Health; Gartner C, Bromberg M et. al.

Aug 16th, 2018 - Vaporised nicotine products (VNPs) that are not approved as therapeutic goods are banned in some countries, including Australia, Singapore, and Thailand. We reviewed two non-profit regulatory options, private clubs and the Australian Therapeutic Goods Administration Special Access Scheme (SAS) that have been applied to other controlled substances (such as cannabis) as a potential model f...

Trial probes mechanism of THC-CBD improvement of multiple sclerosis spasticity
https://www.mdedge.com/familymedicine/article/87410/multiple-sclerosis/trial-probes-mechanism-thc-cbd-improvement-multiple
Clinical Neurology News; Sharon Worcester

Sep 18th, 2014 - BOSTON – A tetrahydrocannabinol and cannabidiol (THC-CBD) oromucosal spray significantly improved spasticity symptoms in a randomized, placebo-controlled study of 43 multiple sclerosis patients. The spray, which goes by the trade name Sativex, has been shown to reduce symptoms associated with spasticity in MS, and is approved in several European countries and commercially licensed in man.