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WORLD OF GENERIC DRUGS MODULE
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Abbreviated New Drug Review Process
Learning Objectives
Introduction
Pre-Filing Review
The Review Process
Residual Sovents
International Conference on Harmonization Guidelines
Improving Efficiency
Knowledge Check
FAQ
Certificate of Completion
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Knowledge Check
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
True.
False.
For the purpose of ANDA approval, which of the following characteristics of a drug product are evaluated?
Polymorphism.
Hygroscopicity.
Bioequivalence.
All of the above.
With regard to the review of original ANDAs, which of the following may not be identified for expedited review?
Products that respond to public health emergencies.
Products with premium sponsorship from large pharmaceutical companies.
Products for which a nationwide shortage has been identified.
Products under special review programs.
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