Pre market approval pma - Study guides, Class notes & Summaries

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

RAC Sample Exam Questions and Answers | Latest Version | 2024/2025 | 100% Pass What is the primary function of the International Organization for Standardization (ISO)? A) To regulate pharmaceutical pricing B) To develop and publish international standards C) To conduct clinical trials D) To market medical devices Which regulatory body oversees the approval of medical devices in Europe? A) FDA B) European Medicines Agency (EMA) C) Health Canada D) World Health Organization (W...

2014 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed Which regulatory pathway allows for faster approval of drugs that address unmet medical needs in serious conditions? A) Priority Review B) Orphan Drug Designation C) Accelerated Approval D) Fast Track Designation Which document must be provided to participants to ensure they understand the risks and benefits of a clinical trial? A) Investigator’s Brochure B) Informed Consent Form C) Clinic...

US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified). drug, which of the following studies would typically be conducted first: A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients:  B) Single dose esca- lation PK study in healthy volunteers 3. A sponsor must report an unexpected, fatal or life...

US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers). In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial us...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...

US RAC Questions With Complete Solutions Latest Update 2024 (100% Verified Answers) In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approve...

Oberon's RAC Drugs Questions and Answers TEA process ANSWER 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) ANSWER ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt ANSWER no effectiveness data required misbranded device ANSWER not cleared through 510k process (but needs one) adultered device ANSWER does not have PMA but needs one design input for device ANSWER requirements that must be met I...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...

SOCRA CCRP Exam Questions and Answers Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1....