Biologics control act - Study guides, Class notes & Summaries

BCPS Regulatory Exam Questions and Answers FDA office of commissioner - ANSWER top office senate confirmation overall agency coordination FDA office of chief counsel - ANSWER legal affairs FDA office of regulatory affairs - ANSWER largest office all inspection and enforcement center for drug eval and research - ANSWER CDER regulates rx and non rx drugs ANDA - ANSWER abbreviated NDA submit to CDER review and ultimate approval of a generic product authorized generic drug - ANSWER m...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement r...

NAPSRX PRACTICE QUESTIONS EXAM QUESTIONS WITH COMPLETE ASNWERS Which area of R&D has seen the largest cost increases? clinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? 10-15 years Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)? Pharmaceutical Research and Manufacturers of America (PhRMA) Which of the following factors has simplified the pharmaceutical R&D ...

NAPSRx Practice Exam Questions With 100% Correct Answers Which area of R&D has seen the largest cost increases? - answerclinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? - answer10-15 years Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)? - answerPharmaceutical Research and Manufacturers of America (PhRMA) Which of the following factors has simplified the pha...

pharmacology for nurses Chamberlain College Nursing -Exam 1 Pharmacology for Nurses (Ch 1-5) questions with answersWhat is the difference between therapeutic and pharmacologic classifications? Identify the following classifications as therapeutic or pharmacologic: beta-adrenergic blocker, oral contraceptive, laxative, folic acid antagonist, and antianginal drug. - correct answer The therapeutic classification is a method of organizing drugs based on their therapeutic usefulness in treating parti...

MPJE ILLINOIS VERIFIED ANSWERS Form to send to DEA for destroying controls DEA Form 41 Controlled substance theft/loss form? DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! How long to send in theft/loss form? 1 business day Do you need to report pseudophedrine as stolen? No, it is a C5 under state law but not controlled under federal law Difference between detox and maintenance treatment with methadone/LAAM Detox = <...

NAPSRx Practice Exam Questions With 100% Correct Answers Which area of R&D has seen the largest cost increases? - answerclinical trials On average, how long does a new drug take to be developed (from discovery of initial compound to FDA approval)? - answer10-15 years Which of the following regulatory agencies is industry-based (run mainly by the companies themselves)? - answerPharmaceutical Research and Manufacturers of America (PhRMA) Which of the following factors has simplified the pha...

Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - CORRECT ANSWER-A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver-Harris Amendments (1:2) - CORRECT ANSWER-D: Kefauver-Harris Am...

Drug Discovery - • Unlike small molecule drugs (pharmaceuticals), large molecule drugs (biopharmaceuticals) are mainly protein-based o These protein-based drugs are similar to natural biological compounds found in human body or they're fragments that mimic active part of natural compounds Discovery of Pharmaceuticals - commences w/ scanning hundreds of compounds, whether w/ actual materials (irrational approach) or virtual simulations (rational approach) • Pharmaceuticals are new chem...

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 F...