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Summary BCPS – Regulatory questions and answers 2024
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BCPS – Regulatory questions and answers 2024
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BCPS – Regulatory questions and answers2024
FDA office of commissioner - top office
senate confirmation
overall agency coordination
FDA office of chief counsel - legal affairs
FDA office of regulatory affairs - largest office
all inspection and enforcement
center for drug eval and research - CDER
regulates rx and non rx drugs
ANDA - abbreviated NDA
submit to CDER
review and ultimate approval of a generic product
authorized generic drug - marketed sold or distributed directly or indirectly with:
labeling
,BCPS – Regulatory questions and answers
2024
packaging
product code
labeler code
trade name
or trademark
that differs from that of the listed drug
BLA - biologics license application
effects of biologic product seeking approval in US
clinical trial - 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 - investigational new drug application
used for new drug, antibiotic or biologic
, BCPS – Regulatory questions and answers
2024
using in clinical investigations preclinical dev
allows new drug to be dist across state lines before full FDA review
NDA - new drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in
US
drug importation act of 1848 - prohibited the importation of unsafe or adulterated
drugs at key points of entry
biologics control act of 1902 - 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 - prohibited interstate commerce of adulterated or
misbranded drugs
required labeling of selected dangerous and addictive substances
identified USP and NF as official standards
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