US FDA and pharmaceutical companies agree on increased fees for faster approvals

2002 ◽  
Vol 358 (1) ◽  
pp. 11-11
2018 ◽  
Vol 6 (2) ◽  
pp. 48-53
Author(s):  
Lakshmi Ananth ◽  
Nirmal K. Gurbani ◽  
Saurabh Kumar ◽  
Bharat Gujavarti

This paper provides contemporary climate of warning letters issued by US FDA over 2015 to 2017. With 1300$ Billion Revenue in 2017 United States stands as World’s largest Pharmaceutical Market. Being the largest, diversified and due to globalization, US Pharma industry is the most competitive and critical sectors of the economy. So, exporting to the US is a great opportunity which is leveraged by many countries and US FDA was formed to check the quality standards of Medicines. Since the inception of US FDA, it has been giving many warning letters to Pharmaceutical Companies for violating regulatory guidelines. The back bone of this paper is to analyse warning letters and to identify what are the major violations in case of Pharmaceuticals.


2020 ◽  
Vol 47 (2) ◽  
pp. 228-234
Author(s):  
Miran Han ◽  
Jongbin Kim

Chloral hydrate (CH) has been used in sedation for over 100 years. CH was first synthesized in 1832, the sedative properties were observed in 1861. Because of its easy synthesis, its use was widespread since 1869. There is a record of the use of CH in children as early as 1894. Recently there have been many controversies about safety of CH. Because of the low cost and relatively safe experience CH has still been used for dental sedation in children. After the US FDA recommendation in 2006, US pharmaceutical companies no longer produce commercial CH. However, CH has been used in the form of suspensions prepared from raw materials in many areas of the United States, and reports of adverse events related to death have continued.<br/>CH is the most commonly used drug for sedation in Korea, and there have been some reports of side effects.<br/>Dexmedetomidine, propofol and midazolam were introduced as an alternative for CH. There are various limitations in using them in the pediatric dentistry area and there are many things to consider.<br/>The purpose of this review is to analyze the complications of CH and status of use in Korea, and to introduce alternatives to CH.


Terminology ◽  
2014 ◽  
Vol 20 (1) ◽  
pp. 74-91 ◽  
Author(s):  
Pascaline Faure

In times past, drugs often derived from plants and were quite naturally named after them. Nowadays, considering the significant economic issues at stake (Dutchen 2009), pharmaceutical companies increasingly entrust brand agencies with the naming of their products (Kenagy 2001). In this article, we offer to analyze the names of some brand and generic drugs, exploiting the French VIDAL dictionary, the British National Formulary and the US FDA corpora, with the aim to bring to light the evolution of lexical trends over the last century. Whilst doing so, we wish to demonstrate that, in the field of pharmacology, the process of naming is nowadays not so much underlain by a legitimate need for clarity and scientificity but rather by marketing strategies some of which prove to be misleading for patients. Considering the now international dimension of the pharmaceutical industry, drug names are often the same around the world. Yet, there are exceptions, which we point out and explain. Furthermore, we deemed interesting to underline the extent to which medicines are part of our everyday life by pointing out nicknames that patients tend to give to their treatments — usually sedatives, neuroleptics and the like — and metaphors they may resort to in English and in French. We conclude with the acknowledgement that medicines are henceforth like any other goods, whose financial stakes are such that, besides developing forceful new names, the pharmaceutical industry goes so far as inventing new diseases (disease mongering) to increase its market share (Even and Debré 2012).


2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.


2020 ◽  
Vol 17 (1) ◽  
pp. 58-67
Author(s):  
N. A. Kabanova ◽  
I. K. Alekseeva

The article is devoted to the assessment of potential investment risks of the pharmaceutical company “R-Pharm” JSC with the aim of identifying the highest priority risks and developing methods for minimizing them. The relevance of the study is determined by the fact that the pharmaceutical business is characterized by a high degree of social orientation and annually invests $ 140 billion in the development of production and research, which determines the need for a risk-based approach to ensure the return on investment. The subject of this article is the investment risks of pharmaceutical companies, and the subject of research is the domestic pharmaceutical company “R-Pharm”. In order to assess the potential investment risks of “R-Pharm” JSC, the authors used elements of simulation modeling and system analysis. The proposed methods to minimize key investment risks are aimed at improving the efficiency of investment activities and is recommended as an element of the strategic planning of the company.


Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.


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