RAC-Drugs Exam Questions With Correct
Answers
Food |& |Drug |Administration |(FDA) |- |CORRECT |ANSWER✔✔-Agency |of |Dept. |of |Health |& |
Human |Services |(HHS). |Protects |public |health |by |assuring |safety, |efficacy, |and |security |of |
human |drugs |and |biological |products. |Inspects |imported |goods. |Works |with |foreign |bodies |
and |external |agencies |to |ensure |medicinal |products |are |safe |and |secure |for |human |use.
Office |of |Regulatory |Affairs |(ORA) |- |CORRECT |ANSWER✔✔-Inspects |and |reviews |products |
offered |for |entry |into |US. |Implement |policies |and |outreaches |for |product |portfolios.
Office |of |Global |Policy |& |Strategy |(OGPS) |- |CORRECT |ANSWER✔✔-serves |as |a |pan-agency |
coordinator, |information |distributor, |and |access |point |for |multilateral |organizations. |Addresses |
international |trade |of |regulated |products |and |mutual |recognition |agreements, |facilitates |
information |with |global |counterparts, |and |manages |FDA's |foreign |offices.
Office |of |International |Products |(OIP) |- |CORRECT |ANSWER✔✔-coordinates |the |FDA's |
international |work |to |help |foster |partnerships |with |counterpart |foreign |agencies |and |
international |orgs. |Offices |focus |on |specific |regions: |Latin |America |(Costa |Rica); |Europe |
(Brussels, |London); |China |(Beijing), |and |India |(New |Delhi).
Confidentiality |Commitment |- |CORRECT |ANSWER✔✔-sets |up |legal |framework |for |FDA |to |share
|certain |kinds |of |non-public |info |with |international |orgs |and |regulators |in |other |countries |as |
part |of |cooperative |law |enforcement |or |regulatory |activities.
Cooperative |Arrangements |- |CORRECT |ANSWER✔✔-written |document |that |describes |the |
good-faith |intentions |of |the |FDA, |other |regulators, |and |international |orgs |to |engage |in |
cooperative |activities.
, International |Committee |for |Harmonisation |of |Technical |Requirements |for |Pharmaceuticals |for |
Human |Use |(ICH) |- |CORRECT |ANSWER✔✔-develops |guidelines |based |on |scientific |discussions |
among |regulatory |authorities |and |the |pharmaceutical |industry. |guidelines |are |updated |
continuously. |Mission |is |to |achieve |greater |harmonization |worldwide |and |ensure |that |safe, |
effective, |and |high-quality |medicines |are |developed, |registered, |and |maintained |in |the |most |
resource-efficient |manner |while |meeting |high |standards.
Office |of |Global |Affairs |(OGA) |- |CORRECT |ANSWER✔✔-Provides |leadership |and |expertise |in |
global |health |diplomacy |to |contribute |to |a |safer, |healthier |world.
European |Medicines |Agency |(EMA) |- |CORRECT |ANSWER✔✔-Protects |and |promotes |human |
and |animal |health |by |evaluating |and |monitoring |medicines |with |the |EU.
Centralised |Procedure |- |CORRECT |ANSWER✔✔-EMA |gives |opinion, |resulting |in |single |
marketing |authorization |(MA) |for |whole |of |EU.
National |Procedure |- |CORRECT |ANSWER✔✔-individual |member |states |authorize |medicines |for
|use |in |their |territory.
International |Council |for |Harmonisation |(ICH) |- |CORRECT |ANSWER✔✔-promote |public |health; |
contribute |to |the |development, |manufacturing, |and |supervision |of |new |medicines, |and |
develop |technical |guidelines |that |can |be |implemented |by |regulatory |bodies
Medical |Dictionary |for |Regulatory |Activities |(MedDRA) |- |CORRECT |ANSWER✔✔-highly |specific,
|standardized |medical |terminology |used |to |facilitate |sharing |of |regulatory |info |used |for |
registration, |documentation, |and |safety |monitoring |of |medical |products |before |and |after |
marketing |authorization
Medicinal |Product |Development |Continuum |- |CORRECT |ANSWER✔✔-1. |Discovery |& |
development
2. |Pre-clinical |research
Answers
Food |& |Drug |Administration |(FDA) |- |CORRECT |ANSWER✔✔-Agency |of |Dept. |of |Health |& |
Human |Services |(HHS). |Protects |public |health |by |assuring |safety, |efficacy, |and |security |of |
human |drugs |and |biological |products. |Inspects |imported |goods. |Works |with |foreign |bodies |
and |external |agencies |to |ensure |medicinal |products |are |safe |and |secure |for |human |use.
Office |of |Regulatory |Affairs |(ORA) |- |CORRECT |ANSWER✔✔-Inspects |and |reviews |products |
offered |for |entry |into |US. |Implement |policies |and |outreaches |for |product |portfolios.
Office |of |Global |Policy |& |Strategy |(OGPS) |- |CORRECT |ANSWER✔✔-serves |as |a |pan-agency |
coordinator, |information |distributor, |and |access |point |for |multilateral |organizations. |Addresses |
international |trade |of |regulated |products |and |mutual |recognition |agreements, |facilitates |
information |with |global |counterparts, |and |manages |FDA's |foreign |offices.
Office |of |International |Products |(OIP) |- |CORRECT |ANSWER✔✔-coordinates |the |FDA's |
international |work |to |help |foster |partnerships |with |counterpart |foreign |agencies |and |
international |orgs. |Offices |focus |on |specific |regions: |Latin |America |(Costa |Rica); |Europe |
(Brussels, |London); |China |(Beijing), |and |India |(New |Delhi).
Confidentiality |Commitment |- |CORRECT |ANSWER✔✔-sets |up |legal |framework |for |FDA |to |share
|certain |kinds |of |non-public |info |with |international |orgs |and |regulators |in |other |countries |as |
part |of |cooperative |law |enforcement |or |regulatory |activities.
Cooperative |Arrangements |- |CORRECT |ANSWER✔✔-written |document |that |describes |the |
good-faith |intentions |of |the |FDA, |other |regulators, |and |international |orgs |to |engage |in |
cooperative |activities.
, International |Committee |for |Harmonisation |of |Technical |Requirements |for |Pharmaceuticals |for |
Human |Use |(ICH) |- |CORRECT |ANSWER✔✔-develops |guidelines |based |on |scientific |discussions |
among |regulatory |authorities |and |the |pharmaceutical |industry. |guidelines |are |updated |
continuously. |Mission |is |to |achieve |greater |harmonization |worldwide |and |ensure |that |safe, |
effective, |and |high-quality |medicines |are |developed, |registered, |and |maintained |in |the |most |
resource-efficient |manner |while |meeting |high |standards.
Office |of |Global |Affairs |(OGA) |- |CORRECT |ANSWER✔✔-Provides |leadership |and |expertise |in |
global |health |diplomacy |to |contribute |to |a |safer, |healthier |world.
European |Medicines |Agency |(EMA) |- |CORRECT |ANSWER✔✔-Protects |and |promotes |human |
and |animal |health |by |evaluating |and |monitoring |medicines |with |the |EU.
Centralised |Procedure |- |CORRECT |ANSWER✔✔-EMA |gives |opinion, |resulting |in |single |
marketing |authorization |(MA) |for |whole |of |EU.
National |Procedure |- |CORRECT |ANSWER✔✔-individual |member |states |authorize |medicines |for
|use |in |their |territory.
International |Council |for |Harmonisation |(ICH) |- |CORRECT |ANSWER✔✔-promote |public |health; |
contribute |to |the |development, |manufacturing, |and |supervision |of |new |medicines, |and |
develop |technical |guidelines |that |can |be |implemented |by |regulatory |bodies
Medical |Dictionary |for |Regulatory |Activities |(MedDRA) |- |CORRECT |ANSWER✔✔-highly |specific,
|standardized |medical |terminology |used |to |facilitate |sharing |of |regulatory |info |used |for |
registration, |documentation, |and |safety |monitoring |of |medical |products |before |and |after |
marketing |authorization
Medicinal |Product |Development |Continuum |- |CORRECT |ANSWER✔✔-1. |Discovery |& |
development
2. |Pre-clinical |research
