FDA - Drugs/Biologics Flashcards
What does FDA stand for?
Food and Drug Administration
True or False: The FDA is responsible for regulating the safety and effectiveness of drugs and biologics.
True
What is the primary purpose of FDA regulations?
To ensure the safety, efficacy, and security of drugs and biologics.
Fill in the blank: The FDA requires that all new drugs undergo _____ before they can be marketed.
clinical trials
What is a biologic?
A product derived from living organisms that is used in the diagnosis, prevention, or treatment of diseases.
Multiple choice: Which of the following is NOT regulated by the FDA?
Cosmetics
What is the role of the New Drug Application (NDA)?
To seek FDA approval for a new drug after clinical trials.
True or False: The FDA has the authority to withdraw approval of a drug after it has been marketed.
True
What are the three phases of clinical trials?
Phase 1, Phase 2, Phase 3
Fill in the blank: The FDA’s _____ is responsible for evaluating the safety and effectiveness of biologics.
Center for Biologics Evaluation and Research
What is the purpose of the Investigational New Drug (IND) application?
To allow a drug to be tested in humans during clinical trials.
Multiple choice: Which of the following is a requirement for drug approval by the FDA?
Proving safety and efficacy through clinical trials
What is post-marketing surveillance?
Monitoring the safety of a drug after it has been approved and marketed.
True or False: The FDA can impose penalties for violations of drug regulations.
True
What does the term ‘orphan drug’ refer to?
A drug developed for a rare disease affecting fewer than 200,000 people in the U.S.
Fill in the blank: The _____ program allows for expedited review of drugs that treat serious conditions.
Fast Track
What is the purpose of the FDA’s Risk Evaluation and Mitigation Strategies (REMS)?
To ensure that the benefits of a drug outweigh its risks.
Multiple choice: Which of the following does NOT require FDA approval?
Dietary supplements
What is a drug label?
The information provided by the manufacturer about the drug’s use, dosage, and side effects.
True or False: The FDA conducts inspections of manufacturing facilities.
True
What is a 510(k) submission?
A premarket submission demonstrating that a device is at least as safe and effective as a legally marketed device.
Fill in the blank: The _____ is a system for reporting adverse events related to drug use.
FDA Adverse Event Reporting System (FAERS)
What is the difference between a drug and a dietary supplement?
Drugs are intended to diagnose, cure, mitigate, treat, or prevent disease, while dietary supplements are intended to supplement the diet.
Multiple choice: Which entity advises the FDA on scientific and technical issues?
Advisory committees
True or False: The FDA’s regulations apply only to products sold in the United States.
True
What is the significance of the Drug Enforcement Administration (DEA) in relation to the FDA?
The DEA regulates controlled substances, which are also subject to FDA approval.
