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Generic drug companies were required to repeat the extensive and costly clinical trials that the brand companies had performed to prove the efficacy and safety of the drug. Generic drug companies no longer had to prove safety and effectiveness of their drugs from the ground up, as the branded compan...

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Bibliographic Details
Published in:Travel medicine and infectious disease 2020, Vol.33
Main Author: Nancy Piper Jenks
Format: Review
Language:English
Subjects:
Clinical trials
Collaboration
Companies
Drug resistance
Drugs
FDA approval
Generic drugs
Infectious diseases
Low income groups
Manufacturing
Manufacturing industry
Pharmaceutical industry
Prescription drugs
Travel medicine
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Summary:Generic drug companies were required to repeat the extensive and costly clinical trials that the brand companies had performed to prove the efficacy and safety of the drug. Generic drug companies no longer had to prove safety and effectiveness of their drugs from the ground up, as the branded companies did, with costly clinical trials. In the generic drug industry where minimizing cost in production and maximizing profit is a goal, it can hardly be surprising that certain companies have falsified data and run manufacturing plants without regard to principles of safe practices.
ISSN:1477-8939
1873-0442
DOI:10.1016/j.tmaid.2019.101550