A) You intend to conduct a clinical trial with an investigational new drug
B) You intend to conduct a clinical trial with an approved drug to support a
marketing application for a new indication
C) You intend to collect blood samples from subjects to look for biomarkers
or pharmacogenetic information
D) You intend to conduct a clinical trial using 2 of your approved drugs in a
new combination - ANSWER-C) You intend to collect blood samples from
subjects to look for biomarkers or pharmacogenetic information
In the clinical development plan for an investigational antihypertensive drug,
which of the following studies would typically be conducted first:
A) 1 month repeat dose toxicology study
,B) Single dose escalation PK study in healthy volunteers
C) Multiple dose PK study in healthy volunteers
D) Single dose escalation study in hypertensive patients - ANSWER-B) Single
dose escalation PK study in healthy volunteers
A sponsor must report an unexpected, fatal or life-threatening experience
believed to be associated with an unapproved drug/biologic:
A) to FDA, investigators and IRBs within 7 calendar days
B) to FDA and investigators within 7 calendar days
C) to FDA within 14 calendar days
D) to FDA and investigators within 7 working days - ANSWER-B) to FDA and
investigators within 7 calendar days
Which of the following is a covered study as defined under Financial
Disclosure regulations:
A) Phase I dose escalation study
B) Phase I/II Pharmacokinetic Study
C) A large open label safety study conducted at a large number of study sites
,D) Phase III pivotal study - ANSWER-D) Phase III pivotal study
You, a regulatory affairs professional, are assessing the information to be
submitted in support of a marketing application for a new dosage form for a
listed drug. You lack right of reference to one key preclinical report. Which
type of application will you prepare for submission?
A) 505 (b) (1)
B) 505 (b) (2)
C) 505 (j)
D) PMA - ANSWER-B) 505 (b) (2)
8) If FDA were to invoke the Application Integrity Policy, which of the
following is a possible outcome?
A) Defer review of pending application(s)
B) "File" a marketing application at the 60 day review
C) Grant a waiver or deferral for pediatric clinical study
D) Approve a marketing application - ANSWER-A) Defer review of pending
application(s)
, Your company is developing a product to treat a serious and life threatening
disease. A clinically meaningful, well established primary endpoint will be
used in the pivotal studies. Which regulatory strategy might you select prior
to commencing Phase 3 studies?
A) Request Special Protocol Assessment
B) Request Fast Track Designation
C) Request Priority Review
D) Approval under Subpart H, Accelerated Approval of New Drugs for Serious
or Life Threatening Illnesses - ANSWER-A) Request Special Protocol
Assessment
As a regulatory affairs professional, you are responsible for developing the
content of an information package for a Type B meeting with FDA. Your
primary objective is to:
A) Reach consensus on content from contributing team members
B) Ensure content is sufficient to support meeting objective(s) and questions
to FDA
C) Provide appropriate preclinical summary
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