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Q1. What are pharmaceutical regulatory agencies primarily concerned with? a. Ens

ID: 123212 • Letter: Q

Question

Q1. What are pharmaceutical regulatory agencies primarily concerned with?
    a. Ensuring product quality and product efficacy
    b. Policing research strategies employed by pharmaceutical corporations
    c. Regulating the number of products produced by pharmaceutical corporations
    d. Policing the testing of pharmaceutical products

Q2. As the general population ages, long-term care increasingly focuses on:
    a. Serving patients suffering from dementia
    b. Serving patients suffering from infectious diseases
    c. Increased employment of powerful experimental drugs
    d. Raising money through charitable contributions

Q3. What does the Orphan Drug Act of 1983 allow for?
    a. Modifying approaches to new drug authorization and marketing to improve the economic advantages for new drugs in limited markets
    b. The adoption of unpatented drugs by various pharmaceutical companies
    c. Government control over new, potentially life-saving drugs
    d. Increased government regulation over drugs developed for limited markets

Explanation / Answer

Ans 1. The correct option is a,ie ensuring product quality and product efficacy. Because quality is directly related to the safety of the drug for use in human population and the main aim of a regulatory agency is to ensure the safety and efficacy of the drug.

Ans 2: the correct answer is d , raising money through charitable contributions. Because the growing age bulk is increasing every year leading to lack of resources for better long-term care and therefore a good financial support is to be focused.

Ans 3: The correct answer is a, modifying approaches to new drug authorization and marketing to improve the economic advantages for new drugs in the limited market. Like it reduces the number of patients to be included in a trail from 1000 to least because orphan drugs are used for rare diseases and it not possible to find 1000 patients to approve the trail.