RAC ACTUAL EXAM 2026 VERIFIED
QUESTIONS AND SOLUTIONS
◉True or False: Quarterly adverse event safety reporting is typically
required for the first five years postapproval for an ANDA or
NDA.(13:1). Answer: False. Quarterly reporting is required for the
first three years.
◉True or False: A supplement to propose a moderate level change as
defined in the 21 CFR 314.70 would be submitted as a Prior
Approval Supplement.(13:2). Answer: False. It can be submitted as a
changes being effected supplement.
◉True or False: The FDA. Answer: s Scale-Up and Post Approval
Changes (SUPAC) guidance documents present four possible levels
of changes with a Level 4 change having the most potential to
change the quality and performance of a drug product (safety or
effectiveness).(13:3) ; False. There are no Level 4 changes defined
within SUPAC.
◉True or False: Annual Reports must be submitted within 30 days
of the anniversary date of the approval of the marketing
, application.(13:4). Answer: False. They need to be submitted within
60 days of the anniversary date.
◉True or False: Drug Master Files must be prepared in Common
Technical Document format.(13:5). Answer: False. There is no
requirement to prepare DMF in CTD format, although it is highly
recommended.
◉True or False: Foreign drug establishments whose drugs are
imported or offered for import into the US must also comply with
the establishment registration and drug listing requirements.(13:6).
Answer: True.
◉If a company wants to seek approval of a proposed drug product in
a new capsule dosage form (the listed drug upon which the generic
applicant would rely is in a table dosage form), what type of
submission should be made to FDA?(14:1). Answer: The company
could seek approval of either an ANDA pursuant to an approved
suitability petition, or the company could submit a 505(b)(2)
application.
◉If the company in question 1 (14:1) decides to submit a 505(b)(2)
application containing only comparative
bioequivalence/bioavailability information, would that applicant
qualify for a period of three-year exclusivity?(14:2). Answer: No. In
order for a company to qualify for three-year exclusivity, the sponsor
must submit "reports of new clinical investigations (other than
QUESTIONS AND SOLUTIONS
◉True or False: Quarterly adverse event safety reporting is typically
required for the first five years postapproval for an ANDA or
NDA.(13:1). Answer: False. Quarterly reporting is required for the
first three years.
◉True or False: A supplement to propose a moderate level change as
defined in the 21 CFR 314.70 would be submitted as a Prior
Approval Supplement.(13:2). Answer: False. It can be submitted as a
changes being effected supplement.
◉True or False: The FDA. Answer: s Scale-Up and Post Approval
Changes (SUPAC) guidance documents present four possible levels
of changes with a Level 4 change having the most potential to
change the quality and performance of a drug product (safety or
effectiveness).(13:3) ; False. There are no Level 4 changes defined
within SUPAC.
◉True or False: Annual Reports must be submitted within 30 days
of the anniversary date of the approval of the marketing
, application.(13:4). Answer: False. They need to be submitted within
60 days of the anniversary date.
◉True or False: Drug Master Files must be prepared in Common
Technical Document format.(13:5). Answer: False. There is no
requirement to prepare DMF in CTD format, although it is highly
recommended.
◉True or False: Foreign drug establishments whose drugs are
imported or offered for import into the US must also comply with
the establishment registration and drug listing requirements.(13:6).
Answer: True.
◉If a company wants to seek approval of a proposed drug product in
a new capsule dosage form (the listed drug upon which the generic
applicant would rely is in a table dosage form), what type of
submission should be made to FDA?(14:1). Answer: The company
could seek approval of either an ANDA pursuant to an approved
suitability petition, or the company could submit a 505(b)(2)
application.
◉If the company in question 1 (14:1) decides to submit a 505(b)(2)
application containing only comparative
bioequivalence/bioavailability information, would that applicant
qualify for a period of three-year exclusivity?(14:2). Answer: No. In
order for a company to qualify for three-year exclusivity, the sponsor
must submit "reports of new clinical investigations (other than
