What is the process of approval by the FDA for health product operations?

Pharmam3me3(2)

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English
•
10th Grade
•
Hard
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1.
FLASHCARD QUESTION
Front
Back
Registration is the process of approval by the FDA of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, testing, promotion, advertisement, and/or sponsorship of health products.
2.
FLASHCARD QUESTION
Front
What are the privileges of senior citizens regarding discounts on medicines?
Back
Senior citizens are entitled to a 20% discount on medicines and a 20% discount on dental, medical, and laboratory services in government facilities.
3.
FLASHCARD QUESTION
Front
What is the minimum shear stress that must be applied before a system begins to flow?
Back
The minimum shear stress is known as the Yield value.
4.
FLASHCARD QUESTION
Front
According to Stokes' Law, what affects the rate of sedimentation?
Back
The rate of sedimentation will be higher if the viscosity of the medium is lower.
5.
FLASHCARD QUESTION
Front
How do you determine the first-order rate constant from the amount of drug remaining?
Back
The first-order rate constant can be determined using the formula for first-order kinetics, which in this case results in 0.258/hr.
6.
FLASHCARD QUESTION
Front
What is Licensing in the context of health products?
Back
Licensing is the process of obtaining permission from a regulatory authority to operate in a specific capacity, such as manufacturing or distributing health products.
7.
FLASHCARD QUESTION
Front
What is the difference between Registration and Certification?
Back
Registration is the process of formally recording an establishment with a regulatory body, while Certification is the process of verifying that a product or service meets specific standards.
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