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WorksheetsCLPT, MRA 103T, Regulations Governing Clinical Trials.
Total questions: 15
Worksheet time: 15mins
What is the505(b)(1) Application?
Application for Approval of Generic Drug
Application for Approval of New Drug
Application for Approval of New Drug that relies on data not developed by the applicant
Application for Approval of Medical Device
What is the 505(b)(2) Application?
Application for Approval of Generic Drug
Application for Approval of New Drug
Application for Approval of New Drug that relies on data not developed by the applicant
Application for Approval of Medical Device
What is the 505(j) Application?
Application for Approval of Generic Drug
Application for Approval of New Drug
Application for Approval of New Drug that relies on data not developed by the applicant
Application for Approval of Medical Device
What is the meaning of RTA by US FDA?
Refuse to Accept
Refuse to Agree
Revised to Accept
Revised to Agree
What is the meaning of RTF by US FDA?
Refuse to Follow
Refuse to File
Revised to File
Revised to Follow
21 CFR Part 50 refers to?
Financial Disclosure by Clinical Investigators
Institutional Review Boards
Protection of Human Subjects
Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 58 refers to?
Financial Disclosure by Clinical Investigators
Institutional Review Boards
Protection of Human Subjects
Good Laboratory Practice for Nonclinical Laboratory Studies
Applications for FDA Approval to Market a New Drug?
21 CFR Part 314
21 CFR Part 312
21 CFR Part 601
21 CFR Part 814
Investigational New Drug Application?
21 CFR Part 314
21 CFR Part 312
21 CFR Part 601
21 CFR Part 814
Applications for FDA Approval of a Biologic License?
21 CFR Part 314
21 CFR Part 312
21 CFR Part 601
21 CFR Part 814
What id PDUFA?
Prescription Drug User Fee Application
Prescription Drug User Fee Act
What is GDUFA?
(a)
ANDA Fee as per FY 2021?
$ 196,868
$ 176,237
$ 69,921
$ 57,795
NDA Fee as per FY 2021?
$2,942,965
$2,875,842
$1,471,483
$1,437,921
New Drugs and Clinical Trials Rules 2019 - CDSCO is Replacement of?
Schedule C
Schedule X
Schedule Y
Schedule H
