1.

What does IND stand tor in the

context of drug approval?
• A) Investigative New Drug
• B) Initial New Drug
• C) lnvestigational New Drug
• D) Institutional New Drug
2 • What is the primary purpose of
submitting an IND application?
• A) To market a new drug
• B) To conduct clinical trials in
humans
• C) To obtain a patent for a new drug
• D) To get FDA approval for a new
manufacturing process
3. Which section of the IND
application provides details about
the drug's pharmacology and
toxicology?
• A) General lnvestigational Plan
• B) Investigator's Brochure
• C) Chemistry, Manufacturing, and
Controls (C~. +
 • C) Chemistry, Manufacturing, and
Controls (CMC)
• D) Clinical Protocols
4. What does NDA stand for?
• A) New Drug Authorization
• B) New Drug Application
• C) National Drug Administration
• D) New Drug Assessment
5 • What is the goal of an NDA?
• A) To obtain approval to market a
new drug in the U.S.
• B) To begin clinical trials for a new
drug
• C) To receive patent protection for a
new drug
• D) To get FDA feedback on a drug's
development plan
6 • Which of the following is a
requirement for an NDA
submission?
• A) Detailed r + 'ts of animal studies
• A) Detailed results of animal studies
• B) Data from clinical trials
demonstrating the drug's safety and
efficacy
• C) Summary of the drug's
mechanism of action
• D) All of the above
7. What does ANDA stand for?
• A) Advanced New Drug Application
• B) Abbreviated New Drug
Application
• C) Alternative New Drug Approval
• D) Accelerated New Drug
Application
8. The ANDA process is primarily
used for what type of drugs?
• A) New molecular entities
• B) Generic drugs
• C) Over-the-counter drugs
• D) Biologic drugs
 9 • Which is NOT typically required in
an ANDA?
• A) Bioequivalence studies
• B) Safety and efficacy clinical trials
• C) Chemistry, Manufacturing, and
Controls (CMC) information
• D) Labeling information
10 . What is the primary purpose of
bioequivalence studies in an
ANDA submission?
• A) To demonstrate that the generic
drug is as effective as the original
drug
• B) To show that the generic drug is
more cost-effective than the original
drug
• C) To prove that the generic drug
has the same safety profile as the
original drug
• D) To confirm that the generic drug
has the same dosage form as the
original drug +
11. Which of the following is a critical
component of the NDA review
process?
• A) Preclinical animal testing
• B) Phase 1 clinical trials
• C} FDA inspection of manufacturing
facilities
• D) Post-marketing surveillance
12 . What is the role of the Institutional
Review Board (IRB) in the IND
process?
• A) To review and approve the
marketing plan
• B} To oversee clinical trials and
protect human subjects
• C) To conduct pharmacological
assessments
• D} To provide regulatory approval for
manufacturing
13 . How long does the FDA typically
have to review an NDA
submission?
• A) 30 days
• B) 60 days
• C) 180 days
• D) 365 days
14 • Which of the following phases is
NOT part of the clinical trial
process under an IND?
• A) Phase 0
• B) Phase 1
• C) Phase 2
• D) Phase 4
15 • Which type of application would
be used to seek approval for a
biologic drug?
• A) IND
• B) NDA
• C) ANDA
• D) BLA
16 . What does BLA stand for?
• A) Biologic License Application
• B) Biological Line Approval
• C) Bioequivalence Licensing
Agreement
• D) Biopharmaceutical Licensing
Application
17. What is the key difference
between NDA and ANDA
submissions?
• A) NDA is for new drugs, while ANDA
is for generic drugs
• B) NDA requires bioequivalence
studies, while ANDA does not
• C) NDA is submitted to the EMA,
while ANDA is submitted to the FDA
• D) NDA includes labeling
information, while ANDA does not
18 • Which of the following is true
about the expedited review
programs IY i "le FDA?
 programs by the FDA?
• A) They are only available for generic
drugs
• B) They aim to speed up the
approval of drugs that address
unmet medical needs
• C) They eliminate the need for
clinical trials
• D) They are applicable only for over-
the-counter drugs
19. What is a 505(b)(2) application?
• A) An application for a new
molecular entity
• B) An NDA application that relies on
data not developed by the applicant
• C) An application for a generic drug
• D) An application for biologic drugs
20. What must be submitted to the
FDA for an IND to become
effective?
• A) An approved NOA
• B) Clinical trial data from Phase 3
studies
• C) Notice of Claimed lnvestigational
Exemption for a New Drug
• D) Bioequivalence studies