Podcast
Questions and Answers
What is a TPP in the context of drug development?
What is a TPP in the context of drug development?
In the context of a New Drug Application, what does NDA stand for?
In the context of a New Drug Application, what does NDA stand for?
Which regulation subpart governs the accelerated approval of new drugs for serious or life-threatening illnesses?
Which regulation subpart governs the accelerated approval of new drugs for serious or life-threatening illnesses?
What does FDASIA stand for and what is its significance in drug regulation?
What does FDASIA stand for and what is its significance in drug regulation?
Signup and view all the answers
What does GLP stand for in the context provided?
What does GLP stand for in the context provided?
Signup and view all the answers
Which type of device presents a potential for serious risk to the subject's health and is intended for use in supporting or sustaining human life?
Which type of device presents a potential for serious risk to the subject's health and is intended for use in supporting or sustaining human life?
Signup and view all the answers
What is an excipient in the context of drug formulation?
What is an excipient in the context of drug formulation?
Signup and view all the answers
Which pathway allows earlier approval of drugs to treat serious diseases based on surrogate endpoints?
Which pathway allows earlier approval of drugs to treat serious diseases based on surrogate endpoints?
Signup and view all the answers
What does CDER represent in the context provided?
What does CDER represent in the context provided?
Signup and view all the answers
Which of the following is NOT a correct definition of IND?
Which of the following is NOT a correct definition of IND?
Signup and view all the answers
What is the name of the committee or panel used by the FDA to obtain independent expert advice on scientific, technical, and policy matters?
What is the name of the committee or panel used by the FDA to obtain independent expert advice on scientific, technical, and policy matters?
Signup and view all the answers
Which database contains reports of adverse events involving medical devices?
Which database contains reports of adverse events involving medical devices?
Signup and view all the answers
What does a 505(b)(2) application under the FD&C Act refer to?
What does a 505(b)(2) application under the FD&C Act refer to?
Signup and view all the answers
Which set of research ethics principles for human experimentation was created in response to medical atrocities during World War II?
Which set of research ethics principles for human experimentation was created in response to medical atrocities during World War II?
Signup and view all the answers
What does 'NSR' stand for in the context of medical devices?
What does 'NSR' stand for in the context of medical devices?
Signup and view all the answers
What is meant by a 'Humanitarian Device Exemption'?
What is meant by a 'Humanitarian Device Exemption'?
Signup and view all the answers
'YOHAN' in the context of medical devices refers to:
'YOHAN' in the context of medical devices refers to:
Signup and view all the answers
'PACS' in the context of medical devices stands for:
'PACS' in the context of medical devices stands for:
Signup and view all the answers
What does RLD stand for in the context of drug products?
What does RLD stand for in the context of drug products?
Signup and view all the answers
Under which act was a process established for drug approval based on comparison to already approved products?
Under which act was a process established for drug approval based on comparison to already approved products?
Signup and view all the answers
What does HCT/P stand for in the context of human cells and tissues?
What does HCT/P stand for in the context of human cells and tissues?
Signup and view all the answers
Which category does 21 CFR parts 500s refer to?
Which category does 21 CFR parts 500s refer to?
Signup and view all the answers
Under which regulation should manufacturers and initial importers of devices register their establishments?
Under which regulation should manufacturers and initial importers of devices register their establishments?
Signup and view all the answers
Which regulation pertains to Human Cells, Tissues, and Tissue-Based Products?
Which regulation pertains to Human Cells, Tissues, and Tissue-Based Products?
Signup and view all the answers
'Investigation New Drug (application)' is associated with which abbreviation?
'Investigation New Drug (application)' is associated with which abbreviation?
Signup and view all the answers
What is the purpose of a serious enforcement letter issued by the FDA?
What is the purpose of a serious enforcement letter issued by the FDA?
Signup and view all the answers
What is included in a Device Master Record?
What is included in a Device Master Record?
Signup and view all the answers
What does the term 'Pharmacovigilance' refer to?
What does the term 'Pharmacovigilance' refer to?
Signup and view all the answers
What type of meeting is required to help a stalled product development program proceed, scheduled within 30 days of FDA receipt of a written request?
What type of meeting is required to help a stalled product development program proceed, scheduled within 30 days of FDA receipt of a written request?
Signup and view all the answers
Which event would prompt the scheduling of a Type A Meeting according to FDA guidelines?
Which event would prompt the scheduling of a Type A Meeting according to FDA guidelines?
Signup and view all the answers
In the context provided, what is NOT a purpose for holding a Type A Meeting according to FDA guidance?
In the context provided, what is NOT a purpose for holding a Type A Meeting according to FDA guidance?
Signup and view all the answers
Which term describes the compilation of records containing procedures and specifications of a finished medical device?
Which term describes the compilation of records containing procedures and specifications of a finished medical device?
Signup and view all the answers
