FDA Exam 1 2023 Solved 100% Correct

Definition of Drug: - ANSWER-any product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and it is intended to affect the structure or any function of the body Step 1 of New Drug Development - ANSWER-Animals tested for toxicity Step 2 of New drug development: - ANSWER-IND application (Investigational new drug), based on the results from initial testing to include the drugs composition and manufacturing Step 3 of new drug development: - ANSWER--Phase 1 clinical trials -20-80 patients -emphasizes safety -determine drugs most frequent side effects and how drug is metabolized and excreted Step 4 of New drug Development: - ANSWER--Phase 2 clinical trials -100 patients -emphasizes effectiveness -obtain prelim data on if drug works on people with certain disease or condition -safety is still evaluated Step 5 of New drug Development: - ANSWER--Phase 3 -1000s of patients -gather more information about safety and effectiveness -study different populations and dosages -tests combinations with other drugs Step 6 of new drug development: - ANSWER--review meeting -FDA meets with drug sponsor prior to submission of a new drug application Step 7 of new drug development: - ANSWER--NDA application -drug sponsors asks FDA to approve drug for marketing -NDA includes all human and animal data, hot it behaves Step 8/9 of new drug development: - ANSWER--application is reviewed -after NDA is received FDA has 60 days Step 10 of new drug development: - ANSWER--drug labeling -FDA reviews drugs professional labeling Step 11 of new drug development: - ANSWER--facility inspection -FDA inspects the facility where drug is being manufactured Step 12 of new drug development: - ANSWER--drug approval -FDA reviewers will approve the application or issue a response letter Prescription Drug User Fee Act (PDUFA) - ANSWER-Authorizes FDA to collect user fees from drug companies to expedite the drug approval process Biosimilar User Fee Act (BsUFA): - ANSWER-acilitates the development of safe and effective biosimilar products for the American public Generic Drug User Fee Amendments (GDUFA): - ANSWER-esigned to speed access to safe and effective generic drugs to the public, and reduce costs to industry. 505(b)(1) - ANSWER-pathway for new drug applications (NDA) to develop reference listed drug -new drug, never introduced 505(b)(2) - ANSWER-pathway for drugs that reference NDA but with different strength, different dosage form, different route of admin, combo of several drugs new formulation of drug -been introduced before but NEW form 505(j) - ANSWER-Same dosage forms, same route of admin, same dosage form only difference is inactive ingredients Purpose of conducting clinical investigations is to: - ANSWER-establish the effect of drug/biologic from influences such as spontaneous change in the course of disease, placebo effect, or biased observation Legislative Branch - ANSWER--makes laws -house of representatives -statutes are codified in US code into 54 title headings -statutes for Food and drugs is found in Title 21 Where is statutes for food and drugs found? - ANSWER-title 21 FD&C act is found in sections: - ANSWER-321 to 399h of title 21 Executive branch: - ANSWER--enforces laws -fifteen branches What is the FDA a part of? - ANSWER-Department of Health and Human Services What is the FDA missions statement? - ANSWER-protect public health by ensuring safety of food, drugs, and cosmetics Judicial branch: - ANSWER--interprets laws