A Generic Drug Primer: Regulatory Aspects and Scientific Concepts

The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1) FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will Explain the process and criteria to request and designate a drug as a CGT. Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT. Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)

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Generic Drug Use Helps Curb Health Care Costs

Internal Medicine News ◽

10.1016/s1097-8690(07)70179-8 ◽

2007 ◽

Vol 40 (4) ◽

pp. 35

Author(s):

ALICIA AULT

Keyword(s):

Health Care ◽

Drug Use ◽

Health Care Costs ◽

Generic Drug ◽

Care Costs

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Bioequivalence Problem Results in Recall of Generic Drug

Internal Medicine News ◽

10.1016/s1097-8690(12)70749-7 ◽

2012 ◽

Vol 45 (17) ◽

pp. 22

Author(s):

ELIZABETH MECHCATIE

Keyword(s):

Generic Drug

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Self-Regulatory Aspects of Bullshitting and Bullshit Detection

Social Psychology ◽

10.1027/1864-9335/a000412 ◽

2020 ◽

Vol 51 (4) ◽

pp. 239-253

Author(s):

John V. Petrocelli ◽

Haley F. Watson ◽

Edward R. Hirt

Keyword(s):

Evidence Based ◽

Regulatory Aspects

Abstract. Two experiments investigate the role of self-regulatory resources in bullshitting behavior (i.e., communicating with little to no regard for evidence, established knowledge, or truth; Frankfurt, 1986 ; Petrocelli, 2018a ), and receptivity and sensitivity to bullshit. It is hypothesized that evidence-based communication and bullshit detection require motivation and considerably greater self-regulatory resources relative to bullshitting and insensitivity to bullshit. In Experiment 1 ( N = 210) and Experiment 2 ( N = 214), participants refrained from bullshitting only when they possessed adequate self-regulatory resources and expected to be held accountable for their communicative contributions. Results of both experiments also suggest that people are more receptive to bullshit, and less sensitive to detecting bullshit, under conditions in which they possess relatively few self-regulatory resources.

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FDA Announces Measures to Improve Generic Drug Access

PsycEXTRA Dataset ◽

10.1037/e362202004-001 ◽

2004 ◽

Author(s):

Keyword(s):

Generic Drug ◽

Drug Access

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Vital Signs: World Prescription Generic Drug Market Is Expected to Climb

Family Practice News ◽

10.1016/s0300-7073(06)73343-6 ◽

2006 ◽

Vol 36 (12) ◽

pp. 1

Keyword(s):

Generic Drug ◽

Vital Signs ◽

Drug Market

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The Application of Science Concepts in Management Research Reports Based on Scientific Truth

Aptisi Transactions on Management (ATM) ◽

10.33050/atm.v2i1.791 ◽

2018 ◽

Vol 2 (1) ◽

pp. 37-44

Author(s):

Hamdy Hady ◽

Henderi Henderi ◽

Dian Mustika Putri

Keyword(s):

General Idea ◽

Research Report ◽

Management Research ◽

Scientific Concepts ◽

Literature Study ◽

Management Activity ◽

Report Writing ◽

Scientific Truth ◽

Scientific Reporting

The management activity of research report writing requires sufficient knowledge in its preparation. A researcher must learn about the management of understanding scientific concepts, as well as management of research reports that are based on scientific truth. In this study, 1 (one) method was used, namely a literature study of 10 (ten) to support the understanding of scientific concepts according to experts. The concept is a general idea that represents perceived understanding on the basis of reason and logic by someone who then forms a meaning deductively or inductively. Whereas knowledge is what is known or the results of work know. Then scientific truth is related to the quality of knowledge, where every knowledge possessed is viewed from the type of knowledge that is built. Thus scientific truth is an important point in scientific reporting, as the basic foundation of accurate management of report writing and must be displayed in every corner of the report. It is hoped that this research can assist researchers in compiling research reports. Keywords: Management, Science, Scientific Truth, Research Reports.

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Light Dramaturgy as an Element of an Integrated Approach to the Creation of Museum Expositions and Exhibition Projects

Light & Engineering ◽

10.33383/2018-158 ◽

2019 ◽

pp. 108-114

Author(s):

Nicolay R. Vorobyov

Keyword(s):

Final Stage ◽

Historical Development ◽

Integrated Approach ◽

Lighting Design ◽

Lighting System ◽

Scientific Concepts ◽

Hands On ◽

Artistic Styles ◽

The Creation

Architectural and artistic construction of museum is one of the most complex genres in environment development and design, with its inherent qualities, means of expressiveness, principles of environment and image development, scientific concepts, in the context of historical development, artistic styles and trends. The author of the article considers the artistic lighting design in isolation from the integral dramaturgy of the project to be deeply flawed, and the setting of accent lighting at the final stage Ц to be simple, but not outstanding. Based on extensive hands-on experience in the construction of museum expositions, the author of the article reveals some peculiarities, especially significant to the participants of the lighting system setting for museums and other cultural facilities.

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