Module 4: Good Clinical Practice: FDA Regulations, FDA Guidance, and ICH 2023/2024 passed

Module 4: Good Clinical Practice: FDA Regulations, FDA Guidance, and ICHThe Code of Federal Regulations (CFR) - correct answer Codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government, including the FDA. Divided into 50 titles and these are assigned to federal regulatory topics and/or government departments and agencies TITLE 21 FDA Part 200-499 - correct answer Drugs Title 21 FDA Part 600-699 - correct answer Biologics Title 21 FDA Part 800-899 - correct answer Medical Devices Title 45 - correct answer Health and human services, OHRP (office of human research protections - the common rule. OCR (Office of civil rights) HIPAA 21 CFR Part 11 - correct answer Electronic records; electronic signatures 21 CFR Part 50 - correct answer Protection of Human subjects 21 CFR Part 54 - correct answer Financial Disclosure by Clinical Investigators 21 CFR Part 56 - correct answer Institutional Review Boards 21 CFR Part 312 - correct answer Investigational New Drug Application 21 CFR Part 314 - correct answer Applications for FDA approval to Market a New Drug