Term
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Definition
| Initiation, Acceleration, Rationalization and Harmonization(ICH) |
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Term
| Who are the different stakeholders involved in the regulatory process? |
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Definition
| healthcare providers, industry and consumers |
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Term
| When was the FD&C act passed? |
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Definition
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Term
| What is GHTF and what does it do? |
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Definition
Global Harmonization Task Force (1992)
To achieve uniformity across national medical device regulatory systems. |
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Term
| GHTF is comprised of which countries? |
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Definition
| EU, US, Canada, Australia and Japan. |
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Term
Veterinary Products fall under the control of drug regulations in EU.
True or False |
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Definition
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Term
TRUE or FALSE
Special drug delivery systems can be CE marked in EU. |
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Definition
FALSE.
They cannot be CE marked and fall under drug regulations in EU. |
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Term
True or False
United States has systems to trace and label GMO's entering the food chain |
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Definition
False.
EU has such systems. |
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Term
True or False
In general, food and dietary supplements and cosmetic products do not need premarket controls. |
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Definition
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Term
True or False
A manufacturer of dietary supplements must be able to show that its product meets minimum safety standards regarding composition, packaging and information |
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Definition
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