RAC EXAM QUESTIONS AND VERIFIED ANSWERS (2026/2027
UPDATE) | GRADED A+ | 100% SUCCESS
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to multiple sites. Which
of the following statements are true? a) Each contract facility must be listed in its own establishment
license application (ELA). b) Each contract facility must be listed in the BLA. c) Each contract facility must
appear in the product labeling. d) Each contract facility must take responsibility for compliance with
applicable establishment and product requirements for biologics. e) b and d f) All of the above(22:1) -
Correct Answer -e) b:Each contract facility must be listed in the BLA and d: Each contract facility must
take responsibility for compliance with applicable establishment and product requirements for biologics.
When FDA receives a biologics license application and determines it to be incomplete the agency may: a)
Issue a "Not Approvable " letter b) Issue a "Refusal to File" letter c) Place a clinical hold on the IND d)
Issue a "Complete Response" letter e) b and d(22:2) - Correct Answer -e) b: Issue a "Refusal to File"
letter and d: Issue a "Complete Response" letter
Biological products are approved for marketing under provisions of: a) Food Drug and Cosmetic Act b)
Acceptable GMP inspection c) Public Heath Service Act d) a and be) All of the above(22:3) - Correct
Answer -e) all of the above
If two or more biotech manufacturers are each registered with FDA and licensed to manufacture a
product in its entirety they are what type of manufacturing arrangement? a) Sole b) Short supply c)
Divided d) Shared e) Contract(22:4) - Correct Answer -c) Divided
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,The Biologics Control Act passed in 1902 authorized or provided for the following: a) Regulation of the
sales of viruses serums toxins and analogous products b) Required licensing of manufacturing
establishments c) Provided inspection authority to the federal government d) All of the above(22:5) -
Correct Answer -d) All of the above
Which of the following statements is true for drugs but not for biologics? a) Adverse events are reported
on Form 3500Ab) Requires Annual Reports to update the IND c ) Approval of labeling and advertising is
required d) Must be manufactured according to GMPs e) All of the above statements are true for
both.(22:6) - Correct Answer -e) All of the above statements are true for both.
If a biological company that FDA believes is causing an imminent hazard to public heath refuses to grant
FDA access to inspect FDA would be justified (by regulation) is using which of the following enforcement
options? a) Issue a Warning Letter b) Immediately suspend the license c) Issue a "Notice to Revoke" d)
Issue an Injunction e) Generate adverse publicity f) b and c(23:1) - Correct Answer -f) b: Immediately
suspend the license and c: Issue a "Notice to Revoke"
Through the Vaccine Adverse Event Reporting System (VAERS) adverse experiences for vaccines are
monitored by: a) CDER b) CBER c) CDC d) b and c e) All of the above(23:2) - Correct Answer -d) b: CBER
and c: CDC
Your company is a licensed manufacturer of a gene therapy product. After release and distribution of a
lot of material it was discovered that one of the release tests was not performed correctly. You as the
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, regulatory professional are required to do the following: a) Issue an NDA Field Alert to the FDA within
three business days. b) Submit within 45 days of the date of discovery of the incident a Biologic Product
Deviation Report to CBER. c) Notify FDA immediately by phone and initiate a product recall before taking
any other actions. d) FDA does not need to be notified. You have determined that there are no concerns
for the safety purity or potency of your product. (23:3) - Correct Answer -b) Submit, within 45 days of the
date of discovery of the incident, a Biologic Product Deviation Report to CBER.
The following changes to an approved biological can be submitted to FDA in an Annual Report: 1)
clarification of the administration statement on the label to ensure proper administration of the product
2) process changes within application/validation ranges 3) site changes within a single facility4) any
change in a specification made to comply with an official compendium 5) changes in the size or shape of a
container for a sterile drug substance6) addition of a stability protocol or comparability protocol a) 1 2 3
and 4 b) 2 3 5 - Correct Answer -and 6c) 2 3 and 4 d) 2 and 4 only e) All of the above(23:4) , a) 1 2 3 and 4
What labeling information should be provided in an initial BLA? a) Label b) Package insert c) Structured
product labeling (SPL)d) All of the above(24:1) - Correct Answer -d) All of the above
What determines whether a REMS is required for a Biologic License Application? a) Elements to assure
safe use b) Need for a Medication Guide c) Only small molecule drugs but not biologics d) None of the
above(24:2) - Correct Answer -a) Elements to assure safe use
An independent peer-reviewed journal article on an off-label use of an approved biologic may be
disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0
days f) 30 days g) 60 days h) 3 months(24:3) - Correct Answer -g) 60 days
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UPDATE) | GRADED A+ | 100% SUCCESS
A manufacturer of a therapeutic vaccine contracts out part of its manufacturing to multiple sites. Which
of the following statements are true? a) Each contract facility must be listed in its own establishment
license application (ELA). b) Each contract facility must be listed in the BLA. c) Each contract facility must
appear in the product labeling. d) Each contract facility must take responsibility for compliance with
applicable establishment and product requirements for biologics. e) b and d f) All of the above(22:1) -
Correct Answer -e) b:Each contract facility must be listed in the BLA and d: Each contract facility must
take responsibility for compliance with applicable establishment and product requirements for biologics.
When FDA receives a biologics license application and determines it to be incomplete the agency may: a)
Issue a "Not Approvable " letter b) Issue a "Refusal to File" letter c) Place a clinical hold on the IND d)
Issue a "Complete Response" letter e) b and d(22:2) - Correct Answer -e) b: Issue a "Refusal to File"
letter and d: Issue a "Complete Response" letter
Biological products are approved for marketing under provisions of: a) Food Drug and Cosmetic Act b)
Acceptable GMP inspection c) Public Heath Service Act d) a and be) All of the above(22:3) - Correct
Answer -e) all of the above
If two or more biotech manufacturers are each registered with FDA and licensed to manufacture a
product in its entirety they are what type of manufacturing arrangement? a) Sole b) Short supply c)
Divided d) Shared e) Contract(22:4) - Correct Answer -c) Divided
1|Page
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,The Biologics Control Act passed in 1902 authorized or provided for the following: a) Regulation of the
sales of viruses serums toxins and analogous products b) Required licensing of manufacturing
establishments c) Provided inspection authority to the federal government d) All of the above(22:5) -
Correct Answer -d) All of the above
Which of the following statements is true for drugs but not for biologics? a) Adverse events are reported
on Form 3500Ab) Requires Annual Reports to update the IND c ) Approval of labeling and advertising is
required d) Must be manufactured according to GMPs e) All of the above statements are true for
both.(22:6) - Correct Answer -e) All of the above statements are true for both.
If a biological company that FDA believes is causing an imminent hazard to public heath refuses to grant
FDA access to inspect FDA would be justified (by regulation) is using which of the following enforcement
options? a) Issue a Warning Letter b) Immediately suspend the license c) Issue a "Notice to Revoke" d)
Issue an Injunction e) Generate adverse publicity f) b and c(23:1) - Correct Answer -f) b: Immediately
suspend the license and c: Issue a "Notice to Revoke"
Through the Vaccine Adverse Event Reporting System (VAERS) adverse experiences for vaccines are
monitored by: a) CDER b) CBER c) CDC d) b and c e) All of the above(23:2) - Correct Answer -d) b: CBER
and c: CDC
Your company is a licensed manufacturer of a gene therapy product. After release and distribution of a
lot of material it was discovered that one of the release tests was not performed correctly. You as the
2|Page
2|Page
, regulatory professional are required to do the following: a) Issue an NDA Field Alert to the FDA within
three business days. b) Submit within 45 days of the date of discovery of the incident a Biologic Product
Deviation Report to CBER. c) Notify FDA immediately by phone and initiate a product recall before taking
any other actions. d) FDA does not need to be notified. You have determined that there are no concerns
for the safety purity or potency of your product. (23:3) - Correct Answer -b) Submit, within 45 days of the
date of discovery of the incident, a Biologic Product Deviation Report to CBER.
The following changes to an approved biological can be submitted to FDA in an Annual Report: 1)
clarification of the administration statement on the label to ensure proper administration of the product
2) process changes within application/validation ranges 3) site changes within a single facility4) any
change in a specification made to comply with an official compendium 5) changes in the size or shape of a
container for a sterile drug substance6) addition of a stability protocol or comparability protocol a) 1 2 3
and 4 b) 2 3 5 - Correct Answer -and 6c) 2 3 and 4 d) 2 and 4 only e) All of the above(23:4) , a) 1 2 3 and 4
What labeling information should be provided in an initial BLA? a) Label b) Package insert c) Structured
product labeling (SPL)d) All of the above(24:1) - Correct Answer -d) All of the above
What determines whether a REMS is required for a Biologic License Application? a) Elements to assure
safe use b) Need for a Medication Guide c) Only small molecule drugs but not biologics d) None of the
above(24:2) - Correct Answer -a) Elements to assure safe use
An independent peer-reviewed journal article on an off-label use of an approved biologic may be
disseminated. How many days prior to dissemination should the information be submitted to FDA? e) 0
days f) 30 days g) 60 days h) 3 months(24:3) - Correct Answer -g) 60 days
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