BCPS UPDATED COMPLETE QUESTIONS
AND CORRECT ANSWERS BUNDLED
RESOURCE
●● 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
AND CORRECT ANSWERS BUNDLED
RESOURCE
●● 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
