R.A.C-Regulatory Affairs Exam
Questions with Actual Detailed Answers.
DHHS - Answer Department of Health and Human Services
FDA protects public health by assessing safety and efficacy in - Answer Foods
Dietary Supplements
cosmetics
veterinary
drugs
medical devices
biologics
tobacco products
statute - Answer law or amendment to a law passed by congress
regulation - Answer rule issued by federal agency
CFR - Answer code of federal regulations
Virus-toxin law/biologics control act - Answer required licensing
vaccine manufacturer inspections
premarket approval of vaccines, serums, and antitoxins
Food and Drugs Act - Answer prohibited marketing adulterated and misbranded food and
drugs
Food, Drug, and Cosmetic Act - Answer strengthened safety and labeling requirements
required FDA to confirm product safety
Durham-Humphrey Amendment - Answer required medications that could be habit forming or
dangerous without oversight to be dispensed with a Rx
Kefauver-Harris Amendment - Answer companies required to demonstrate drug product
efficacy and safety
, FDA given authority to oversee drug advertising
Food and Drug Administration Modernization Act - Answer fast-tracking drugs and biologics
for life-threatening diseases
2007- FDA Amendments Act - Answer imposes risk evaluation and migration strategies (REMS)
Expansion of clinical trial registry database
new office of chief scientist
percent FDA advisory committee members conflict of interest
2012 FDA safety and Innovation Act - Answer expanded user fees from Rx to generic drugs and
biosimilars
1976 Medical Device Amendments - Answer divided devices into 3 classifications based on risk
required FDA premarketing approval of high risk devices
Hatch-Waxman Act - Answer allows generic drug product approval based on bioequivalence
Abbreviated New Drug Application ANDA
Patient Protection and Affordable Care Act - Answer FDA can approve biosimilar and
interchangeable biologic products
Family Smoking Prevention and Tobacco Control Act - Answer FDA authority to regulate
tobacco
FDA budget - Answer 4.74 billon
FDA organization and structure - Answer led by commissioner: nominated by president and
confirmed by senate
Scott Gottlieb
CBER - Answer Center for biologic evaulation and research
CDRH - Answer Center for Device and Radiological
CDER - Answer center for drug evaluation and research
Questions with Actual Detailed Answers.
DHHS - Answer Department of Health and Human Services
FDA protects public health by assessing safety and efficacy in - Answer Foods
Dietary Supplements
cosmetics
veterinary
drugs
medical devices
biologics
tobacco products
statute - Answer law or amendment to a law passed by congress
regulation - Answer rule issued by federal agency
CFR - Answer code of federal regulations
Virus-toxin law/biologics control act - Answer required licensing
vaccine manufacturer inspections
premarket approval of vaccines, serums, and antitoxins
Food and Drugs Act - Answer prohibited marketing adulterated and misbranded food and
drugs
Food, Drug, and Cosmetic Act - Answer strengthened safety and labeling requirements
required FDA to confirm product safety
Durham-Humphrey Amendment - Answer required medications that could be habit forming or
dangerous without oversight to be dispensed with a Rx
Kefauver-Harris Amendment - Answer companies required to demonstrate drug product
efficacy and safety
, FDA given authority to oversee drug advertising
Food and Drug Administration Modernization Act - Answer fast-tracking drugs and biologics
for life-threatening diseases
2007- FDA Amendments Act - Answer imposes risk evaluation and migration strategies (REMS)
Expansion of clinical trial registry database
new office of chief scientist
percent FDA advisory committee members conflict of interest
2012 FDA safety and Innovation Act - Answer expanded user fees from Rx to generic drugs and
biosimilars
1976 Medical Device Amendments - Answer divided devices into 3 classifications based on risk
required FDA premarketing approval of high risk devices
Hatch-Waxman Act - Answer allows generic drug product approval based on bioequivalence
Abbreviated New Drug Application ANDA
Patient Protection and Affordable Care Act - Answer FDA can approve biosimilar and
interchangeable biologic products
Family Smoking Prevention and Tobacco Control Act - Answer FDA authority to regulate
tobacco
FDA budget - Answer 4.74 billon
FDA organization and structure - Answer led by commissioner: nominated by president and
confirmed by senate
Scott Gottlieb
CBER - Answer Center for biologic evaulation and research
CDRH - Answer Center for Device and Radiological
CDER - Answer center for drug evaluation and research
