FDA office of commissioner - ANSWERtop office
senate confirmation
overall agency coordination
FDA office of chief counsel - ANSWERlegal affairs
FDA office of regulatory affairs - ANSWERlargest office
all inspection and enforcement
center for drug eval and research - ANSWERCDER
regula...
FDA office of regulatory affairs - ANSWERlargest office
all inspection and enforcement
center for drug eval and research - ANSWERCDER
regulates rx and non rx drugs
ANDA - ANSWERabbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug - ANSWERmarketed 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 - ANSWERbiologics license application
effects of biologic product seeking approval in US
NDA - ANSWERnew drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in US
drug importation act of 1848 - ANSWERprohibited the importation of unsafe or adulterated drugs at
key points of entry
biologics control act of 1902 - ANSWERannual 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 - ANSWERprohibited 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 - ANSWERevidence of safety before marketing
place drug advertising under FTC
clinical trial - ANSWERresearch 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 - ANSWERinvestigational 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
durham-humphrey amendments of 1962 - ANSWERamended the food, drug and cosmetic act to
differentiate rx and non-rx drugs
kefauver-harris amendments of 1962 - ANSWERefficacy as well as safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
orphan drug act of 1983 - ANSWERgrants, federal assistance for research and tax incentives to
develop targeted drugs for patient population of < 200,000
food and drug administration act of 1988 - ANSWERofficially established the FDA as an agency in
DHHS
food and drug administration amendments act of 2007 - ANSWERreauthorized PDUFA
statutory authority to require RIsk Evaluation Mitigation Strategies (REMS)
family smoking prevention and tobacco control act of 2009 - ANSWERFDA regulates tobacco
products
patient protection and affordable care act of 2010 - ANSWERregulatory approval pathway for
biosimilars or follow-on biologicals
ED 50 - ANSWERamount of drug required to produce a specific effect in 50% of animals tested
LD 50 - ANSWERamount of drug required to cause death in 50% of animals tested
tox studies in preclinical trials - ANSWEReffects on fetus in mice, rats, rabbits or baboons
may or may not translate into human fetus
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