Generic Drugs—A Look Back and a Look Ahead

1990 ◽  
Vol 3 (3) ◽  
pp. 192-202
Author(s):  
Leon Lachman ◽  
Salvatore Turco ◽  
James T. O'Donnell

This review includes the viewpoints of three pharmaceutical scientists tracing the origins of the generic drug industry, examining the recent generic drug controversies, and offering suggestions to hospital practitioners for coping with the controversies.

Author(s):  
Jignesh Prajapati ◽  
Darshit Patel

The US Food and Drug Administration (FDA) and the Generic Drug Industry have completed negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA II). The agreement is now with Congress, which must write it into legislation in order for it to become effective. GDUFA II addresses questions that arose with the implementation of GDUFA I. One of the primary concerns with GDUFA I was that it did not provide any relief for small business whereas GDUFA II addresses relief for small business. GDUFA II has carved out a subcategory for Contract Manufacturing Organizations (CMOs), which are independent facilities contracted by abbreviated new drug application (ANDA) sponsors to manufacture their generic drugs. GDUFA II will have a fee structure very different from GDUFA I. The distribution of user fee categories will show the shift from facilities to applications and the addition of two new user types. GDUFA II is structured to allow FDA to continue on the path forward to improve patient access to quality and affordable generic drugs. As per the GDUFA II commitment, the FDA will work with generic drug makers on a closer and more timely basis to speed the review of ANDAs.


2001 ◽  
Vol 14 ◽  
pp. 53-81 ◽  
Author(s):  
X. Chen ◽  
P. Van Beek

In recent years, many improvements to backtracking algorithms for solving constraint satisfaction problems have been proposed. The techniques for improving backtracking algorithms can be conveniently classified as look-ahead schemes and look-back schemes. Unfortunately, look-ahead and look-back schemes are not entirely orthogonal as it has been observed empirically that the enhancement of look-ahead techniques is sometimes counterproductive to the effects of look-back techniques. In this paper, we focus on the relationship between the two most important look-ahead techniques---using a variable ordering heuristic and maintaining a level of local consistency during the backtracking search---and the look-back technique of conflict-directed backjumping (CBJ). We show that there exists a ``perfect'' dynamic variable ordering such that CBJ becomes redundant. We also show theoretically that as the level of local consistency that is maintained in the backtracking search is increased, the less that backjumping will be an improvement. Our theoretical results partially explain why a backtracking algorithm doing more in the look-ahead phase cannot benefit more from the backjumping look-back scheme. Finally, we show empirically that adding CBJ to a backtracking algorithm that maintains generalized arc consistency (GAC), an algorithm that we refer to as GAC-CBJ, can still provide orders of magnitude speedups. Our empirical results contrast with Bessiere and Regin's conclusion (1996) that CBJ is useless to an algorithm that maintains arc consistency.


2018 ◽  
Vol 28 (4) ◽  
pp. 854-887 ◽  
Author(s):  
Joel R. Evans ◽  
Anil Mathur

Purpose The purpose of this paper is to present a detailed and critical look at the evolution of online survey research since Evans and Mathur’s (2005) article on the value of online surveys. At that time, online survey research was in its early stages. Also covered are the present and future states of online research. Many conclusions and recommendations are presented. Design/methodology/approach The look back focuses on online surveys, strengths and weaknesses of online surveys, the literature on several aspects of online surveys and online survey best practices. The look ahead focuses on emerging survey technologies and methodologies, and new non-survey technologies and methodologies. Conclusions and recommendations are provided. Findings Online survey research is used more frequently and better accepted by researchers than in 2005. Yet, survey techniques are still regularly transformed by new technologies. Non-survey digital research is also more prominent than in 2005 and can better track actual behavior than surveys can. Hybrid surveys will be widespread in the future. Practical implications The paper aims to provide insights for researchers with different levels of online survey experience. And both academics and practitioners should gain insights. Social implications Adhering to a strong ethics code is vital to gain respondents’ trust and to produce valid results. Originality/value Conclusions and recommendations are offered in these specific areas: defining concepts, understanding the future role of surveys, developing and implementing surveys and a survey code of ethics. The literature review cites more than 200 sources.


2011 ◽  
pp. 1288-1288
Author(s):  
Craig Kissock

When preparing for a race, the coach will advise, “Do not look back at your competition; look forward to your goal.” Educators integrating technology into instruction often take this same view; they look ahead to win the race in preparing students to be effective in the use of technology in learning and in life.


Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.


2018 ◽  
Vol 17 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Jonathan J. Darrow ◽  
Reed F. Beall ◽  
Aaron S. Kesselheim
Keyword(s):  

2000 ◽  
Vol 25 (1) ◽  
pp. 107-114 ◽  
Author(s):  
Margaret L. McClure
Keyword(s):  

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