RAC Chapter 1 - FDA and related
regulatory agencies Exam Questions
and Answers
FDA is under? - Answer-Department of health and human services (DHHS)
FDA regulates what types of products? - Answer-Food, dietary supplements, cosmetics,
vet products, drugs, med devices, biologics, tobacco, vaping
Statute vs regulation vs Guidance - Answer-Statute is a law passed by congress,
regulation is a rule issued by a federal agency, guidance is the FDA's current thinking
on its regulations
Biologics control act - Answer-1901 law regulating vaccines, serums and antibodies
Food and drug act - Answer-1906 law preventing the marketing of adulterated or
misbranded drugs
Food, drug and cosmetic act - Answer-1938 law that required FDA to confirm product
safety before it got on the market
Definition of a drug by the food,drug and cosmetic act - Answer-Articles intended for use
in the diagnosis, cure, mitigation, treatment or prevention of disease in man or any other
animal, article being something other than food intended to affect the structure or
function of the body
Durham-Humphrey amendment - Answer-1951 law that allowed certain medications to
be dispensed with a prescription only
Kefauver-Harris amendment - Answer-1962 law required companies to demonstrate
drug product efficacy, safety before approval. Also FDA was given authority to oversee
drug advertising
Food and drug administration modernization act - Answer-1997 law that allowed fast-
tracking of drugs and biologics
Food and drug administration amendments act - Answer-2007 law that gave FDA ability
to impose a risk evaluation and mitigation strategies (REMS)
Food and drug administration safety and innovation act - Answer-2012 act that allowed
FDA to ask for user fees for generic drugs and biosimilars + plus breakthrough
designation
regulatory agencies Exam Questions
and Answers
FDA is under? - Answer-Department of health and human services (DHHS)
FDA regulates what types of products? - Answer-Food, dietary supplements, cosmetics,
vet products, drugs, med devices, biologics, tobacco, vaping
Statute vs regulation vs Guidance - Answer-Statute is a law passed by congress,
regulation is a rule issued by a federal agency, guidance is the FDA's current thinking
on its regulations
Biologics control act - Answer-1901 law regulating vaccines, serums and antibodies
Food and drug act - Answer-1906 law preventing the marketing of adulterated or
misbranded drugs
Food, drug and cosmetic act - Answer-1938 law that required FDA to confirm product
safety before it got on the market
Definition of a drug by the food,drug and cosmetic act - Answer-Articles intended for use
in the diagnosis, cure, mitigation, treatment or prevention of disease in man or any other
animal, article being something other than food intended to affect the structure or
function of the body
Durham-Humphrey amendment - Answer-1951 law that allowed certain medications to
be dispensed with a prescription only
Kefauver-Harris amendment - Answer-1962 law required companies to demonstrate
drug product efficacy, safety before approval. Also FDA was given authority to oversee
drug advertising
Food and drug administration modernization act - Answer-1997 law that allowed fast-
tracking of drugs and biologics
Food and drug administration amendments act - Answer-2007 law that gave FDA ability
to impose a risk evaluation and mitigation strategies (REMS)
Food and drug administration safety and innovation act - Answer-2012 act that allowed
FDA to ask for user fees for generic drugs and biosimilars + plus breakthrough
designation
