Regulatory Status
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2021 ◽  
Vol 5 (4) ◽  
pp. 388
Author(s):  
Mohd Akhtar Ali ◽  
Hamiduddin

Qarābādhīn can be termed as pharmacopoeia, contains compiled form of compound formulations or recipes. Importance of Qarābādhīn gradually increased and acquired an imperative status. The history of Qarābādhīn starts from Chiron, Aesculapius, Hippocrates, Dioscorides and Galen in Greco-Roman era. Many of early and medieval Islamic and Arab physicians play vital role and immense original contribution in this discipline and authored important and essential Qarābādhīn with systemic and scientific approaches. Although some of them could not reach the present day, many of the manuscripts can be found in various libraries across the world. Since the Arab Caliphates appreciated and patronized the fields of medicine acquired from Greeks and worked for its development, this period also known as “Greco-Arabic era”. In this work the evaluation of Qarābādhīn (particularly written in Arabic or Greek language) was done in historical and regulatory perspective particularly in Greek era and later on in Medieval Islamic era. The findings of the review indicate the importance and regulatory status of Qarābādhīn and provide information about it. It can be helpful to explore Qarābādhīn and related publications of Greek and Medieval Islamic Arabic period, which gives foundations for the present-day pharmacopeias. Since these documents also take into account ethical considerations, its utility in the fields of medicine and medical ethics should be investigated.International Journal of Human and Health Sciences Vol. 05 No. 04 October’21 Page: 388-404


Author(s):  
David R. Peaper ◽  
Daniel D. Rhoads ◽  
Kaede V. Sullivan ◽  
Marc R. Couturier ◽  
Romney M. Humphries ◽  
...  

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 regulate the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization EUA pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated in order to continue to be marketed as an IVD in the U.S. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.


2021 ◽  
Vol 19 (S1) ◽  
Author(s):  
Anne Ammerdorffer ◽  
Mark Laws ◽  
Arinze Awiligwe ◽  
Florence Erb ◽  
Wallada Im-Amornphong ◽  
...  

AbstractThe World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.


Author(s):  
Dorina V. Pinkhasova ◽  
Laura E. Jameson ◽  
Kendra D. Conrow ◽  
Michael P. Simeone ◽  
Allan Peter Davis ◽  
...  

Coronaviruses ◽  
2020 ◽  
Vol 01 ◽  
Author(s):  
Kuldeep Singh ◽  
Dilpreet Singh ◽  
Karan Razdan

Objective: Coronavirus Diease-2019 (COVID-19) is a pandemic outbreak in the world and is the leading cause of Severe Acute Respiratory Syndrome (SARS). Methods: Currently, many drugs/therapies have been tested for COVID-19 which responded sub optimally to the patients. Remdesivir is a RNA polymerase inhibitor found promising results in ongoing clinical trials and shows faster recovery rate in COVID-19 patients. Currently, USFDA approves for emergent use of this drug in severe COVID-19 patients. Results: In this review, we discussed brief overview of biopharmaceutical and pharmacological aspects of Remdesivir. Moreover, ongoing regulatory status of Remdesivir by official bodies has also been described.


2020 ◽  
Vol 66 (03) ◽  
pp. 15-16
Author(s):  
Tanja Petreska Ivanovska ◽  
Zoran Zhivikj ◽  
Lidija Petrushevska-Tozi
Keyword(s):  

2020 ◽  
Vol 117 (33) ◽  
pp. 19792-19798 ◽  
Author(s):  
Alvin E. Roth ◽  
Stephanie W. Wang

We study popular attitudes in Germany, Spain, the Philippines, and the United States toward three controversial markets—prostitution, surrogacy, and global kidney exchange (GKE). Of those markets, only prostitution is banned in the United States and the Philippines, and only prostitution is allowed in Germany and Spain. Unlike prostitution, majorities support legalization of surrogacy and GKE in all four countries. So, there is not a simple relation between public support for markets, or bans, and their legal and regulatory status. Because both markets and bans on markets require social support to work well, this sheds light on the prospects for effective regulation of controversial markets.


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