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Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration Cover

Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

Acta Marisiensis - Seria Medica
Volume 68 (2022): Issue 1 (March 2022)
By: M Vivek Reddy,  GNK Ganesh,  B Babu,  Ramesh Jagadeesan and  Praharsh Kumar MR  
Open Access
|Apr 2022

Authors

M Vivek Reddy

Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, India

GNK Ganesh

gnk@jssuni.edu.in

Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, India

B Babu

Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, India

Ramesh Jagadeesan

Department of Analytical and Product development. Recipharm Pharmaservices, Bangalore, India

Praharsh Kumar MR

Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, India
DOI: https://doi.org/10.2478/amma-2022-0004 | Journal eISSN: 2668-7763 | Journal ISSN: 2668-7755
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Language: English
Page range: 28 - 34
Submitted on: Dec 6, 2021
Accepted on: Mar 7, 2022
Published on: Apr 13, 2022
Published by: University of Medicine, Pharmacy, Science and Technology of Targu Mures
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
generic drug exclusivity,
competitive generic therapy,
patent challenge exclusivity
Related subjects:
Medicine,
Clinical medicine,
Clinical medicine, other

© 2022 M Vivek Reddy, GNK Ganesh, B Babu, Ramesh Jagadeesan, Praharsh Kumar MR, published by University of Medicine, Pharmacy, Science and Technology of Targu Mures
This work is licensed under the Creative Commons Attribution 4.0 License.

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