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BCPS – Regulatory Exam Questions & Answers 100% Accurate!!
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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...

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  • October 8, 2024
  • 16
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • bcps regulatory exam questions answ
  • bcps regulatory exam stuvia
  • fda office of commissioner answertop office sen
  • fda office of chief counsel answerlegal affairs
  • fda office of commissioner a

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BCPS – Regulatory Exam 2024-2025
Questions & Answers 100% Accurate!!

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

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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