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BCPS – Regulatory: Questions & Answers
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BCPS – Regulatory: Questions & Answers
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BCPS – Regulatory: Questions & AnswersFDA office of commissioner ✔️Ans -top office
senate confirmation
overall agency coordination
FDA office of chief counsel ✔️Ans -legal affairs
FDA office of regulatory affairs ✔️Ans -largest office
all inspection and enforcement
center for drug eval and research ✔️Ans -CDER
regulates rx and non rx drugs
ANDA ✔️Ans -abbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug ✔️Ans -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 ✔️Ans -biologics license application
effects of biologic product seeking approval in US
clinical trial ✔️Ans -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 ✔️Ans -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 ✔️Ans -new drug application
formal proposal that FDA approve new pharmaceutical for sale and
marketing in US
drug importation act of 1848 ✔️Ans -prohibited the
importation of unsafe or adulterated drugs at key points of entry
biologics control act of 1902 ✔️Ans -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 ✔️Ans -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 ✔️Ans -evidence of safety
before marketing
place drug advertising under FTC
durham-humphrey amendments of 1962 ✔️Ans -amended the
food, drug and cosmetic act to differentiate rx and non-rx drugs
kefauver-harris amendments of 1962 ✔️Ans -efficacy as well as
safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
orphan drug act of 1983 ✔️Ans -grants, federal assistance for
research and tax incentives to develop targeted drugs for patient
population of < 200,000
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