Bcps regulatory - Study guides, Class notes & Summaries

BCPS Policy/Regulatory 2023 questions with complete solutions

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...

FDA office of commissioner - ANSWER top office senate confirmation overall agency coordination Food and Vet medicine (baby food animals) Global reg. operations and policy (reg stuff) Chief scientest (tox reserach

BCPS – Regulatory QUESTIONS WITH COMPLETE SOLUTIONS

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

New drug approval pathway - ANSWER NDA (New Drug Application) Generic drug approval pathway - ANSWER ANDA (Abbreviated New Drug Application) FDA's duties - ANSWER 1. Review and approval of NDA and ANDA 2. Determine if REMS is necessary

authorization bills - ANSWER grant authority for a program or agency to exist appropriation - ANSWER sum of money designated for a particular purpose by an act or bill entitilement spending - ANSWER for programs such as Medicare, Medicaid, and Social Security is automatically set according to eligible recipients. Levels of spending can be changed only by eligibility criteria changes

What are the three core elements required for a controlled substance diversion prevention program? - ANSWER core administrative elements, system level controls, and provider level controls What are the 4 components of a system level control? - ANSWER automation and technology, HR management, monitoring and surveillance, and investigation and reporting

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...