Podcast
Questions and Answers
What is a TPP in the context of drug development?
What is a TPP in the context of drug development?
- Target Product Profile (TPP) (correct)
- Warning letter (WL)
- Recall
- Fd&c Act Of 1938
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?
- IND
- NDA (correct)
- ADME
- BLA
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?
- 10 CFR 314 Subpart H
- 21 CFR 628 Subpart H
- 21 CFR 314 Subpart H (correct)
- 21 CFR 312 Subpart E
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?
What does GLP stand for in the context provided?
What does GLP stand for in the context provided?
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?
What is an excipient in the context of drug formulation?
What is an excipient in the context of drug formulation?
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?
What does CDER represent in the context provided?
What does CDER represent in the context provided?
Which of the following is NOT a correct definition of IND?
Which of the following is NOT a correct definition of IND?
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?
Which database contains reports of adverse events involving medical devices?
Which database contains reports of adverse events involving medical devices?
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?
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?
What does 'NSR' stand for in the context of medical devices?
What does 'NSR' stand for in the context of medical devices?
What is meant by a 'Humanitarian Device Exemption'?
What is meant by a 'Humanitarian Device Exemption'?
'YOHAN' in the context of medical devices refers to:
'YOHAN' in the context of medical devices refers to:
'PACS' in the context of medical devices stands for:
'PACS' in the context of medical devices stands for:
What does RLD stand for in the context of drug products?
What does RLD stand for in the context of drug products?
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?
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?
Which category does 21 CFR parts 500s refer to?
Which category does 21 CFR parts 500s refer to?
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?
Which regulation pertains to Human Cells, Tissues, and Tissue-Based Products?
Which regulation pertains to Human Cells, Tissues, and Tissue-Based Products?
'Investigation New Drug (application)' is associated with which abbreviation?
'Investigation New Drug (application)' is associated with which abbreviation?
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?
What is included in a Device Master Record?
What is included in a Device Master Record?
What does the term 'Pharmacovigilance' refer to?
What does the term 'Pharmacovigilance' refer to?
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?
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?
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?
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?
