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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?

IND

NDA (correct)

ADME

BLA

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?

FDASIA Signup and view all the answers

What does GLP stand for in the context provided?

Good Laboratory Practice 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?

Significant Risk Device Signup and view all the answers

What is an excipient in the context of drug formulation?

Excipient Signup and view all the answers

Which pathway allows earlier approval of drugs to treat serious diseases based on surrogate endpoints?

Accelerated Approval Signup and view all the answers

What does CDER represent in the context provided?

CDER Signup and view all the answers

Which of the following is NOT a correct definition of IND?

Clearance 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?

Advisory Committee Signup and view all the answers

Which database contains reports of adverse events involving medical devices?

MAUDE Signup and view all the answers

What does a 505(b)(2) application under the FD&C Act refer to?

505(b)(2) Application 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?

Nuremberg Code of 1947 Signup and view all the answers

What does 'NSR' stand for in the context of medical devices?

NSS Signup and view all the answers

What is meant by a 'Humanitarian Device Exemption'?

Devices for use in the treatment of rare diseases Signup and view all the answers

'YOHAN' in the context of medical devices refers to:

'YOHAN' Signup and view all the answers

'PACS' in the context of medical devices stands for:

'PACS' Signup and view all the answers

What does RLD stand for in the context of drug products?

Reference Listed Drug Signup and view all the answers

Under which act was a process established for drug approval based on comparison to already approved products?

Hatch-Waxman Act Signup and view all the answers

What does HCT/P stand for in the context of human cells and tissues?

Human Cells, Tissues, and Cellular and Tissue-Based Products Signup and view all the answers

Which category does 21 CFR parts 500s refer to?

21 CFR parts 500s Signup and view all the answers

Under which regulation should manufacturers and initial importers of devices register their establishments?

21 CFR 807 Signup and view all the answers

Which regulation pertains to Human Cells, Tissues, and Tissue-Based Products?

21 CFR 1271 Signup and view all the answers

'Investigation New Drug (application)' is associated with which abbreviation?

IND Signup and view all the answers

What is the purpose of a serious enforcement letter issued by the FDA?

To notify of violative activity requiring immediate action Signup and view all the answers

What is included in a Device Master Record?

Procedures and specifications of a finished device Signup and view all the answers

What does the term 'Pharmacovigilance' refer to?

Monitoring and reporting adverse events 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?

Type A Meeting Signup and view all the answers

Which event would prompt the scheduling of a Type A Meeting according to FDA guidelines?

Clinical holds causing development to stall 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?

Reviewing annual progress reports Signup and view all the answers

Which term describes the compilation of records containing procedures and specifications of a finished medical device?

'Device Master Record' Signup and view all the answers