FDA office of commissioner - ANSWER top office
senate confirmation
overall agency coordination
FDA office of chief counsel - ANSWER legal affairs
FDA office of regulatory affairs - ANSWER largest office
all inspection and enforcement
center for drug eval and research - ANSWER CDER
BCPS – Regulatory QUESTIONS &
ANSWERS(LATEST UPDATE
2024)CORRECT 100%
FDA office of commissioner - ANSWER top office
senate confirmation
overall agency coordination
FDA office of chief counsel - ANSWER legal affairs
FDA office of regulatory affairs - ANSWER largest office
all inspection and enforcement
center for drug eval and research - ANSWER CDER
regulates rx and non rx drugs
ANDA - ANSWER abbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug - ANSWER 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 - ANSWER biologics license application
effects of biologic product seeking approval in US
clinical trial - ANSWER 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 - ANSWER 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 - ANSWER new drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in US
drug importation act of 1848 - ANSWER prohibited the importation of unsafe or adulterated
drugs at key points of entry
biologics control act of 1902 - ANSWER 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 - ANSWER 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 - ANSWER evidence of safety before marketing
place drug advertising under FTC
durham-humphrey amendments of 1962 - ANSWER amended the food, drug and cosmetic act
to differentiate rx and non-rx drugs
food and drug administration amendments act of 2007 - ANSWER reauthorized PDUFA
statutory authority to require RIsk Evaluation Mitigation Strategies (REMS)
family smoking prevention and tobacco control act of 2009 - ANSWER FDA regulates tobacco
products
patient protection and affordable care act of 2010 - ANSWER regulatory approval pathway for
biosimilars or follow-on biologicals
ED 50 - ANSWER amount of drug required to produce a specific effect in 50% of animals tested
LD 50 - ANSWER amount of drug required to cause death in 50% of animals tested
tox studies in preclinical trials - ANSWER effects on fetus in mice, rats, rabbits or baboons
may or may not translate into human fetus
fetal events in humans may occur that didnt in animals
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