Food and Drug Administration ( FDA) Flashcards
What does FDA stand for?
Food and Drug Administration
True or False: The FDA is responsible for regulating food safety.
True
Fill in the blank: The FDA is a part of the ________ government.
U.S. federal
What is one of the primary responsibilities of the FDA?
To ensure the safety and efficacy of drugs.
Which of the following does the FDA regulate? (a) Drugs (b) Food (c) Cosmetics (d) All of the above
d) All of the above
True or False: The FDA only oversees pharmaceuticals.
False
What is the process by which the FDA evaluates new drugs?
New Drug Application (NDA) review
What does the FDA require before a new drug can be marketed?
Evidence of safety and efficacy.
What year was the FDA established?
1906
True or False: The FDA can approve medical devices.
True
Fill in the blank: The FDA’s primary goal is to protect public ________.
health
What is the role of the FDA in food labeling?
To ensure labels are truthful and not misleading.
Which act allows the FDA to oversee the safety of food products?
Federal Food, Drug, and Cosmetic Act
What is the FDA’s role in vaccine approval?
To evaluate and approve vaccines for safety and effectiveness.
True or False: The FDA can enforce recalls of unsafe food products.
True
What is the purpose of FDA inspections?
To ensure compliance with regulations.
What does the term ‘GRAS’ stand for in FDA regulations?
‘Generally Recognized As Safe’
Which division of the FDA is responsible for drug evaluation?
Center for Drug Evaluation and Research (CDER)
True or False: The FDA regulates tobacco products.
True
What is the main focus of the FDA’s Center for Food Safety and Applied Nutrition?
To ensure the safety and proper labeling of food products.
What agency does the FDA collaborate with for food safety?
Centers for Disease Control and Prevention (CDC)
What is the FDA’s authority regarding dietary supplements?
To regulate labeling and claims made by manufacturers.
Fill in the blank: The FDA provides guidance on ________ practices for food production.
sanitary
True or False: The FDA has the power to impose fines on companies that violate regulations.
True
What is the FDA’s role in clinical trials?
To oversee and approve the design of clinical trials.
What type of products does the FDA’s Center for Veterinary Medicine regulate?
Animal drugs and animal food.