ROLE OF USFDA EXAM QUESTIONS

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ROLE OF USFDA EXAM QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -26 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: FDA functions

Answer:

Promote and protect public health by only allowing approval of safe and effective drugs.Monitor drugs for continued safety. (recall if needed) Regulate veterinary drugs, medical devices, and most food products.Monitor safety of consumer products.Monitor safety of radiation emitting devices.

Question 2: Drug Listing Act

Answer:

1972 requires drug companies to provide the FDA with a current list of all drugs manufactured for market distribution creates NDC (national drug code)

Question 3: FDA organizations

Answer:

CDER and CBER CVM CDRH NCTR CFSAN ORA

Question 4: Dietary Supplement Health and Education Act

Answer:

1994 addressed need to regulate the labeling claims made for various herbs and dietary supplements.resulted in numerous fines and customers being refunded.

Question 5: Center for veterinary Medicine

Answer:

CVM regulates drug products for veterinary use

Question 6: Elixir of Sulphanilamide

Answer:

1937 prepared using diethylene glycol as a solvent administered mostly to children to treat strep infections antifreeze poisoning 107 people died

Question 7: Public Health Service Act

Answer:

PHS Act 1944 licensing and marketing of biological drug products

Question 8: Center for Drug/Biologic Evaluation and research

Answer:

CDER and CBER regulates most human pharmaceuticals.biological products.

Question 9: Prescription Drug User Fee Act

Answer:

1992 PDUFA allowed FDA to collect fees from drug manufacturers to fund new drug approval process; done to speed up approval process.

Question 10: Prescription Drug Marketing Act

Answer:

1987 intended to reduce risk of aldultered, misbranded, mislabled, drugs entering US through "secondary sources." prohibits re-importation of drugs.prohibits sale, purchase, trade or reselling drug samples.

Question 11: Center for Food safety and applied nutrition

Answer:

CFSAN regulates food, dietary supplements, and cosmetics

Question 12: Drug Product Recalls

Answer:

If drug product presents a threat or potential threat to consumer safety.depth of recall depends on degree of hazard.Class I - use or exposure will cause serious consequences or death.Class II - cause temporary or reversible adverse effects.Class III - use/exposure not likely to cause adverse effects

Question 13: National center for toxicological research

Answer:

NCTR conducts research to define mechanisms of toxicities of products regulated by FDA

Question 14: Black Box Warning

Answer:

other FDA function FDA's strongest labeling requirement for high risk medicines.Label indicates that drug has significant risk of serious adverse effects.labeled to place emphasis on monitoring

Question 15: Durham-Humphrey

Answer:

1951 Separation of prescription and non-prescription defined prescription meds as those that are "unsafe" for self-medication

Question 16: Center for Devices and Radiological Health

Answer:

CDRH regulates medical devices regulates radiation emitting devices.ie. cell phones, microwave ovens

Question 17: Drug Price Competition and Patent term restoration Act

Answer:

1984 aka Hatch-Waxman Act provides simpler process for manufacturers to file ANDA to market generic versions of a drug

Question 18: Office of Regulatory Affairs

Answer:

ORA regulates sites and facilities where human pharmaceuticals are manufactured

Question 19: Kefauver-Harris drug amendment

Answer:

1962 Required to prove safety and effectiveness to FDA before marketing.Advertisements required to show full benefits and risks.Adverse effects required to be reported to FDA

Question 20: Thalidomide disaster

Answer:

1961 Wonder drug for sleeplessness.relieved morning sickness in pregnant women - unknown that it crossed placenta wall.

Caused:

peripheral neuritis = nerve disorder.birth defects; deaf, blind, disfigurement, cleft palette, internal defects.

Question 21: Food, Drug and Cosmetic Act

Answer:

1938 Required demonstration of safety for new drugs.extended control to cosmetics and devices.