Test Bank for BCPPS Latest Update 2025 Questions Solved Correctly
federal food and drug act - Answers drugs cannot be adulterated or misbranded. Mrs Winslow Sooth
Syrup for teething
food drug and cosmetic act - Answers drugs must be proven safe and have adequate directions for use.
sulfanilamide elixir w/ diethylene glycol
orphan drug act - Answers <200,000 incidences in US population. apply for tax credit and hold marketing
rights x7 years
kefauver-harris drug amendment - Answers drug must be effective in intended population. Thalidomide
regulation on pediatric use subsection of product package insert precautions - Answers emphasized
pediatric labeling. discouraged pediatric labeling for most drugs because lack of research in that
population
national childhood vaccine injury act (NCVIA) - Answers limits legal liability of vaccine manufacturers,
provides source of compensation for victims of ADEs 2/2 vaccines. created VAERS reporting database.
stabilized vaccine costs and ensured adequate supply
final rule - Answers clarifies pediatric labeling procedures. able to extrapolate adult efficacy data. can
label for peds use if good adult studies and safety data in kids. excipients pose risk to children.
FDA modernization act (FDAMA) - Answers incentivized peds studies by giving extra 6 months exclusivity
final rule: pediatric studies - Answers broadened FDAMA to include marketed drugs and biologics.
established FDAs authority to require manufacturers to complete peds studies
best pharmaceuticals for children act (BPCA) - Answers established incentives for manufacturers to
ensure safety and efficacy testing done in children. extended 6 month exclusivity provisions of the
FDAMA to 10/2007. created the office of pediatric therapeutics in the FDA. created the foundation of
national institutes of health (NIH) for study of drugs in kids
pediatric research equity act (PREA) - Answers required peds studies on all new NDAs if drug has
potential for use in kids
FDA amendments act - Answers established pediatric advisory committee in FDA. requires NIH to
publish prioritized list every 3 years of meds that still require peds testing
health information technology for economic and clinical health (HITECT) act - Answers promotes use of
EHRs. addresses privacy and security concerns with EHRs
FDA safety and innovation act (FDASIA) - Answers made BPCA and PREA permanent. authorized FDA to
collect fees from manufacturers to support safety initiatives. requires inclusion of subgroups (children)
in clinical trials
federal food and drug act - Answers drugs cannot be adulterated or misbranded. Mrs Winslow Sooth
Syrup for teething
food drug and cosmetic act - Answers drugs must be proven safe and have adequate directions for use.
sulfanilamide elixir w/ diethylene glycol
orphan drug act - Answers <200,000 incidences in US population. apply for tax credit and hold marketing
rights x7 years
kefauver-harris drug amendment - Answers drug must be effective in intended population. Thalidomide
regulation on pediatric use subsection of product package insert precautions - Answers emphasized
pediatric labeling. discouraged pediatric labeling for most drugs because lack of research in that
population
national childhood vaccine injury act (NCVIA) - Answers limits legal liability of vaccine manufacturers,
provides source of compensation for victims of ADEs 2/2 vaccines. created VAERS reporting database.
stabilized vaccine costs and ensured adequate supply
final rule - Answers clarifies pediatric labeling procedures. able to extrapolate adult efficacy data. can
label for peds use if good adult studies and safety data in kids. excipients pose risk to children.
FDA modernization act (FDAMA) - Answers incentivized peds studies by giving extra 6 months exclusivity
final rule: pediatric studies - Answers broadened FDAMA to include marketed drugs and biologics.
established FDAs authority to require manufacturers to complete peds studies
best pharmaceuticals for children act (BPCA) - Answers established incentives for manufacturers to
ensure safety and efficacy testing done in children. extended 6 month exclusivity provisions of the
FDAMA to 10/2007. created the office of pediatric therapeutics in the FDA. created the foundation of
national institutes of health (NIH) for study of drugs in kids
pediatric research equity act (PREA) - Answers required peds studies on all new NDAs if drug has
potential for use in kids
FDA amendments act - Answers established pediatric advisory committee in FDA. requires NIH to
publish prioritized list every 3 years of meds that still require peds testing
health information technology for economic and clinical health (HITECT) act - Answers promotes use of
EHRs. addresses privacy and security concerns with EHRs
FDA safety and innovation act (FDASIA) - Answers made BPCA and PREA permanent. authorized FDA to
collect fees from manufacturers to support safety initiatives. requires inclusion of subgroups (children)
in clinical trials
