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RAC Exam Questions - NJ Edits. 2023 /40 Questions And Answers
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RAC Exam Questions - NJ Edits. 2023 /40 QuestionsAnd Answers
Quiz :Procedure for submission of an application requiring investigations for
approval of a new indication for, or other change from, a listed drug. 505 (B) 1
&2 - √Answer :21 CFR 314.54
Quiz :WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? - √Answer :·
An application that is a duplicate of a listed drug and eligible for approval
under section 505(j)
(see 21 CFR 314.101(d)(9)); or,
· An application in which the only difference from the reference listed drug is
that the extent to
which the active ingredient(s) is absorbed or otherwise made available to the
site of action is
less than the listed drug (21 CFR 314.54(b)(1)); or,
· An application in which the only difference from the reference listed drug is
that the rate at
which its active ingredient(s) is absorbed or otherwise made available to the
site of action is
unintentionally less than that of the listed drug (21 CFR 314.54(b)(2)).
Quiz :180 day exclusivity - √Answer :This means that, in certain circumstances,
an ANDA applicant whose ANDA contains a paragraph
IV certification is protected from competition from subsequent generic
versions of the same drug
product for 180 days after either the first marketing of the first applicant's drug
or a decision of a
court holding the patent that is the subject of the paragraph IV certification to
be invalid or not
infringed.3 This marketing protection is commonly known as "180-day
exclusivity."
Quiz :An applicant intends to add a coarse screen to the opening of a blender,
through which
all individual components of a granulation would pass prior to granulation. The
applicant asks whether this could be considered a change in a control which
would be
, reportable in a Supplement — Changes Being Effected under section VII.C.2.a
of the
guidance. - √Answer :This change is not considered a change in control but an
additional step in the manufacturing process. However, it is not considered a
fundamental change in the manufacturing process. This type of change should
be reported in a Supplement —
Changes Being Effected in 30 Days (section VII.C.1.a).
Quiz :Prior Approval Supplement (Major Change) - √Answer :A major change is
a change that has a substantial potential to have an adverse effect on the
identity, strength, quality, purity, or potency of a drug product as these factors
may relate to the safety or effectiveness of the drug product. A major change
requires the submission of a supplement and approval by FDA prior to
distribution of the drug product made using the change.
Quiz :Supplement - Changes Being Effected in 30 Days (Moderate Change) -
√Answer :A moderate change requires the submission of a supplement to FDA
at least 30 days before the distribution of the drug product made using the
change. The drug product made using a moderate change cannot be
distributed if FDA informs the applicant within 30 days of receipt of the
supplement that a prior approval supplement is required
Quiz :Supplement - Changes Being Effected. (Moderate Change) -
√Answer :FDA may identify certain moderate changes for which distribution
can occur when FDA receives the supplement (§ 314.70(c)(6)). This type of
supplement is called, and should be clearly labeled, a Supplement - Changes
Being Effected. If, after review, FDA disapproves a changes-being effected-in-
30-days supplement or changes-being-effected supplement, FDA may order
the manufacturer to cease distribution of the drug products made using the
disapproved change (§ 314.70(c)(7)).
Quiz :Minor change - to be reported in Annual Report. - √Answer :A minor
change is a change that has minimal potential to have an adverse effect on the
identity, strength, quality, purity, or potency of the drug product as these
factors may relate to the safety or effectiveness of the drug product. The
applicant must describe minor changes in its next Annual Report
Quiz :Special Protocol Assessment - √Answer :FDA will respond within 45 days
whether acceptable or not.
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