BCPS - Regulatory || 100% Verified Answers.
FDA office of commissioner correct answers top office
senate confirmation
overall agency coordination
FDA office of chief counsel correct answers legal affairs
FDA office of regulatory affairs correct answers largest office
all inspection and enforcement
center for drug eval and research correct answers CDER
regulates rx and non rx drugs
ANDA correct answers abbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug correct answers marketed sold or distributed directly or indirectly with:
labeling
packaging
product code
labeler code
trade name
or trademark
that differs from that of the listed drug
BLA correct answers biologics license application
effects of biologic product seeking approval in US
clinical trial correct answers research study of humans conducted to answer specific questions
about:
vaccines
new therapies
new ways to use know treatments
determine whether new drugs are safe and effective
IND correct answers investigational new drug application
used for new drug, antibiotic or biologic
using in clinical investigations preclinical dev
allows new drug to be dist across state lines before full FDA review
NDA correct answers new drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in US
, drug importation act of 1848 correct answers prohibited the importation of unsafe or adulterated
drugs at key points of entry
biologics control act of 1902 correct answers annual licensing of mfg of vaccines, sera,
antitoxins and similar products
authorized the Hygienic Laboratory (precursor to NIH) to conduct inspections for purity and
potency
pure food and drug act of 1906 correct answers prohibited interstate commerce of adulterated or
misbranded drugs
required labeling of selected dangerous and addictive substances
identified USP and NF as official standards
food drug and cosmetic act of 1938 correct answers evidence of safety before marketing
place drug advertising under FTC
durham-humphrey amendments of 1962 correct answers amended the food, drug and cosmetic
act to differentiate rx and non-rx drugs
kefauver-harris amendments of 1962 correct answers efficacy as well as safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
orphan drug act of 1983 correct answers grants, federal assistance for research and tax incentives
to develop targeted drugs for patient population of < 200,000
food and drug administration act of 1988 correct answers officially established the FDA as an
agency in DHHS
prescription drug user fee act of 1992 correct answers drugs, biologics, and medical devices mfgs
must pay fees for product applications, supplements and other services
reauthorized every 5 years (1997, 2002, 2007)
dietary supplement health and education act of 1994 correct answers regulated nutritional
supplements and vitamins
FDA modernization act of 1997 correct answers streamline research
exclusivity provisions for ped drugs
created clinicaltrials.gov : easy access for info on federal and private trials
abstracts of clinical study protocols correct answers required to contain:
summary and purpose of study
recruiting status
criteria for pt participation
location of trial and contact information
FDA office of commissioner correct answers top office
senate confirmation
overall agency coordination
FDA office of chief counsel correct answers legal affairs
FDA office of regulatory affairs correct answers largest office
all inspection and enforcement
center for drug eval and research correct answers CDER
regulates rx and non rx drugs
ANDA correct answers abbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug correct answers marketed sold or distributed directly or indirectly with:
labeling
packaging
product code
labeler code
trade name
or trademark
that differs from that of the listed drug
BLA correct answers biologics license application
effects of biologic product seeking approval in US
clinical trial correct answers research study of humans conducted to answer specific questions
about:
vaccines
new therapies
new ways to use know treatments
determine whether new drugs are safe and effective
IND correct answers investigational new drug application
used for new drug, antibiotic or biologic
using in clinical investigations preclinical dev
allows new drug to be dist across state lines before full FDA review
NDA correct answers new drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in US
, drug importation act of 1848 correct answers prohibited the importation of unsafe or adulterated
drugs at key points of entry
biologics control act of 1902 correct answers annual licensing of mfg of vaccines, sera,
antitoxins and similar products
authorized the Hygienic Laboratory (precursor to NIH) to conduct inspections for purity and
potency
pure food and drug act of 1906 correct answers prohibited interstate commerce of adulterated or
misbranded drugs
required labeling of selected dangerous and addictive substances
identified USP and NF as official standards
food drug and cosmetic act of 1938 correct answers evidence of safety before marketing
place drug advertising under FTC
durham-humphrey amendments of 1962 correct answers amended the food, drug and cosmetic
act to differentiate rx and non-rx drugs
kefauver-harris amendments of 1962 correct answers efficacy as well as safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
orphan drug act of 1983 correct answers grants, federal assistance for research and tax incentives
to develop targeted drugs for patient population of < 200,000
food and drug administration act of 1988 correct answers officially established the FDA as an
agency in DHHS
prescription drug user fee act of 1992 correct answers drugs, biologics, and medical devices mfgs
must pay fees for product applications, supplements and other services
reauthorized every 5 years (1997, 2002, 2007)
dietary supplement health and education act of 1994 correct answers regulated nutritional
supplements and vitamins
FDA modernization act of 1997 correct answers streamline research
exclusivity provisions for ped drugs
created clinicaltrials.gov : easy access for info on federal and private trials
abstracts of clinical study protocols correct answers required to contain:
summary and purpose of study
recruiting status
criteria for pt participation
location of trial and contact information
