Short Answers Your submission must be no more than two-pages, double

Short Answers
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Your submission must be no more than two-pages, double-spaced, and typed in 11 or 12-point font. Your responses must be original and based on your own individual research. For questions 1-4, please use appropriate sources/references to support your answers. Appropriate sources might include regulatory agencies, published articles, and books related to the questions. WIKI is not an acceptable source/reference. Cite your references in the associated content of your answers and provide a reference list on a separate page. The reference page does not count towards the two-page limit.
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1) Please list the regulatory authorities for medical products in the following countries:
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* United States
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* Mexico
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* India
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* China
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* Australia
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2) Briefly define the following:
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* Drug
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* Biologics
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* Medical Devices
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* In Vitro Diagnostics (IVDs)
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* Combination Products
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3) The electronic Common Technical Document (eCTD) is required for the approval of new drugs in multiple countries. Module 1 of the eCTD is region-specific. Modules 2, 3, 4 & 5 are common for all regions. Identify these 4 modules and what data/information is required in each of the modules.
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4) Describe one regulatory challenge (in the past 5 years) in obtaining the approval for a new drug in your country of residence.
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