Which of the following laws requires that all new drug applications be filed with the FDA?
Federal Privacy Act
Drug Listing Act
Food, Drug, and Cosmetic Act
Poison Prevention Packaging Act
Food, Drug, and Cosmetic Act
Rationale: The Food, Drug, and Cosmetic Act requires that all new drug applications must be filed with the FDA. The goals of a new drug application (NDA) include providing information to FDA reviewers to determine the drug's safety, effectiveness, benefits, risks, accuracy of labeling, manufacturing methods, appropriate drug strength, quality, and purity.
You might also like to view...
In interstitial lung disease, which of the following mechanisms contributes to impaired gas ex-change?
1. Depression of respiratory drive 2. Diffusion defect 3. Shunt 4. Ventilation/perfusion mismatch a. 1 and 4 only b. 2 and 3 only c. 2, 3, and 4 only d. 1, 2, and 4
It is duty, or responsibility, that guides the determination for making ethical decisions under __________
Fill in the blank(s) with the appropriate word(s).