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