Japanese-originated pharmaceutical products in the United States from 1960 to 1989: An assessment of innovation

1992 ◽  
Vol 51 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Elma S Hawkins ◽  
Michael R Reich
2003 ◽  
Vol 29 (4) ◽  
pp. 525-542
Author(s):  
Merri C. Moken

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).


2013 ◽  
Vol 91 (6) ◽  
pp. 496-497 ◽  
Author(s):  
William C. Stewart ◽  
Paul G. Chaney ◽  
Jeanette A. Stewart ◽  
Bonnie Kruft ◽  
Lindsay A. Nelson

Subject Trade in pharmaceuticals and narcotics between China and the United States. Significance The flow of drugs between China and the United States -- both legal and illegal -- has a huge impact on each society, especially those going from China to the United States. Leaders in both countries have consciously sought to separate the bilateral trade and trafficking of drugs from their trade war. Impacts Although US pharmaceuticals firms should avoid tariffs on their products, tariffs may affect other areas of their supply chain. Other producers of pharmaceutical products, such as India, could benefit from any active US effort to diversify sources. If China were successfully to curb fentanyl production, production would probably shift to another country with lighter regulation.


2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2457-2462
Author(s):  
Prabhakar V S ◽  
Beula Evangeline C ◽  
Aravindhanathan V ◽  
Sruthi N ◽  
Gowthamarajan K

The intentions of the current study are to compare the regulatory requirements of USFDA and CDSCO-Schedule M in GMP with significance to the pharmaceutical industry to speed up the criteria for enforcement to facilitate the regulatory approval of specified pharmaceutical products in the United States and India. The literature search is done using different resources, such as regulatory authority websites, pharmaceutical review articles, journals and public domains. To discuss the numerous dilemmas, root causes and challenges confront by pharmaceutical companies and to suggest remedial and pro-active measures to GMP issues and all pharmaceutical manufacturers are required to develop and enforce effective quality control systems in order to ensure quality. Whereas the regulated markets like the United States have well-established guidance compared to emerging markets like India on good manufacturing practice compliance, to assess the effectiveness of this quality management systems, inspections are carried out on manufacturing units. The primary objective of the analysis is to differentiate between the type of application or license that causes the inspection and the outcome of the inspection and to also provide enough details identified by the authority during the evaluation.


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