BCPS – Regulatory Final Exam Practice Questions and
Revised Answers 2025/2026
1. FDA office of commissioner: top oflce
senate confirmation
overall agency coordination
2. FDA office of chief counsel: legal attairs
3. FDA office of regulatory affairs: largest oflce all
inspection and enforcement
4. center for drug eval and research: CDER
regulates rx and non rx drugs
5. ANDA: abbreviated NDA
submit to CDER
revieẇ and ultimate approval of a generic product
6. authorized generic drug: marketed sold or distributed directly or indirectly ẇith: labeling
packaging
product code
labeler code
trade name
or trademark
that ditters from that of the listed drug
7. BLA: biologics license application
ettects of biologic product seeking approval in US
,8. clinical trial: research study of humans conducted to ansẇer specific questions about:
vaccines
neẇ therapies
neẇ ẇays to use knoẇ treatments
determine ẇhether neẇ drugs are safe and ettective
9. IND: investigational neẇ drug application used
for neẇ drug, antibiotic or biologic using in
clinical investigations preclinical dev
alloẇs neẇ drug to be dist across state lines before full FDA revieẇ
10. NDA: neẇ drug application
formal proposal that FDA approve neẇ pharmaceutical for sale and marketing in US
, 11. drug importation act of 1848: prohibited the importation of unsafe or adulterated drugs at key points of entry
12. 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
13. 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 oflcial standards
14. food drug and cosmetic act of 1938: evidence of safety before marketing
place drug advertising under FTC
15. durham-humphrey amendments of 1962: amended the food, drug and cosmetic act to
ditterentiate rx and non-rx drugs
16. kefauver-harris amendments of 1962: eflcacy as ẇell as safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
17. orphan drug act of 1983: grants, federal assistance for research and tax incentives to develop targeted
drugs for patient population of < 200,000
18. food and drug administration act of 1988: oflcially established the FDA as an agency in DHHS
19. prescription drug user fee act of 1992: drugs, biologics, and medical devices mfgs must pay fees for
product applications, supplements and other services
Revised Answers 2025/2026
1. FDA office of commissioner: top oflce
senate confirmation
overall agency coordination
2. FDA office of chief counsel: legal attairs
3. FDA office of regulatory affairs: largest oflce all
inspection and enforcement
4. center for drug eval and research: CDER
regulates rx and non rx drugs
5. ANDA: abbreviated NDA
submit to CDER
revieẇ and ultimate approval of a generic product
6. authorized generic drug: marketed sold or distributed directly or indirectly ẇith: labeling
packaging
product code
labeler code
trade name
or trademark
that ditters from that of the listed drug
7. BLA: biologics license application
ettects of biologic product seeking approval in US
,8. clinical trial: research study of humans conducted to ansẇer specific questions about:
vaccines
neẇ therapies
neẇ ẇays to use knoẇ treatments
determine ẇhether neẇ drugs are safe and ettective
9. IND: investigational neẇ drug application used
for neẇ drug, antibiotic or biologic using in
clinical investigations preclinical dev
alloẇs neẇ drug to be dist across state lines before full FDA revieẇ
10. NDA: neẇ drug application
formal proposal that FDA approve neẇ pharmaceutical for sale and marketing in US
, 11. drug importation act of 1848: prohibited the importation of unsafe or adulterated drugs at key points of entry
12. 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
13. 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 oflcial standards
14. food drug and cosmetic act of 1938: evidence of safety before marketing
place drug advertising under FTC
15. durham-humphrey amendments of 1962: amended the food, drug and cosmetic act to
ditterentiate rx and non-rx drugs
16. kefauver-harris amendments of 1962: eflcacy as ẇell as safety
informed consent for research subjects
FDA regulates advertising of rx drugs
established GMP
17. orphan drug act of 1983: grants, federal assistance for research and tax incentives to develop targeted
drugs for patient population of < 200,000
18. food and drug administration act of 1988: oflcially established the FDA as an agency in DHHS
19. prescription drug user fee act of 1992: drugs, biologics, and medical devices mfgs must pay fees for
product applications, supplements and other services
