Marketing New Drugs Flashcards
What is the primary goal of drug marketing?
To promote the safe and effective use of new drugs.
True or False: The FDA is responsible for approving new drugs for marketing in the United States.
True
What are the main phases of clinical trials for new drugs?
Phases 1, 2, and 3.
Fill in the blank: The __________ is the entity that submits a New Drug Application (NDA) to the FDA.
sponsor
What does NDA stand for?
New Drug Application
Which phase of clinical trials primarily assesses the drug’s safety?
Phase 1
True or False: Post-marketing surveillance is unnecessary after a drug is approved.
False
What is a key regulatory requirement before marketing a new drug?
Obtaining FDA approval.
What does the term ‘indications’ refer to in drug marketing?
The specific conditions or diseases for which a drug is approved.
What is the purpose of Phase 3 clinical trials?
To confirm efficacy and monitor adverse reactions in a larger population.
Multiple Choice: Which of the following is NOT a phase of clinical trials? A) Phase 4 B) Phase 5 C) Phase 3
B) Phase 5
What is the role of Institutional Review Boards (IRBs) in drug research?
To review and approve research protocols to ensure the safety and rights of participants.
Fill in the blank: The process of marketing new drugs begins with __________.
preclinical research
What is the primary focus of Phase 2 clinical trials?
To evaluate the drug’s efficacy and side effects.
True or False: The cost of bringing a new drug to market is typically low.
False
What is one major factor contributing to the high cost of drug development?
The lengthy and complex clinical trial process.
What does ‘orphan drug’ mean?
A drug developed for rare diseases affecting a small number of patients.
Multiple Choice: Which entity typically conducts the preclinical testing of new drugs? A) FDA B) Pharmaceutical companies C) Hospitals
B) Pharmaceutical companies
What is the purpose of Phase 4 clinical trials?
To gather additional information about a drug’s risks, benefits, and optimal use after it has been marketed.
Fill in the blank: The __________ is a document that provides evidence of a drug’s effectiveness and safety to the FDA.
New Drug Application (NDA)
What is the significance of the ‘Black Box Warning’?
It highlights serious risks associated with a drug.
True or False: Drug advertisements must comply with FDA regulations.
True
What does ‘informed consent’ mean in the context of clinical trials?
Participants must be fully informed about the study and voluntarily agree to participate.
What is the main reason for conducting post-marketing studies?
To monitor long-term effects and effectiveness in a general population.
