FDA EXAM 2023 Solved 100% Correct

FDA Description - ANSWER-a federal government agency of the United States Department of Health and Human Services, responsible for ensuring the health and safety of consumers regarding drugs, dietary supplements, prescriptions, vaccines, blood transfusions, veterinary products, biologics, food, cosmetics, and medical devices federal food, drug, and cosmetic act - ANSWER-established modern clinical trials pre-clinical trials - ANSWER-the drug is tested on animals and tissues before going on to humans IND - ANSWER-investigational new drug application. gives pre-clinical data to justify the human testing Phase 1 Drug Approval Process - ANSWER-the drug is tested on healthy human volunteers to determine the drug's safety, duration of effects, and establish any possible side effects Phase 2 Drug Approval Process - ANSWER-determines the drug's effectiveness, side effects, and optimal dosage by doing a double-blind controlled study. the control group gets the placebo and the experimental group gets the real drug Phase 3 Drug Approval Process - ANSWER-The same as phase 2 only there are even more people in the studies to gather more information Phase 4 - ANSWER-the drug is monitored while on the market and if anything bad happens then the drug could be pulled off the market FDA stands for: - ANSWER-Food and Drug Administration Compassionate Use Act/ Expanded Access - ANSWER-Is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.