Pre market approval pma Study guides, Class notes & Summaries
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Oberon's RAC Drugs Exam Questions With Complete Answers!!
- Exam (elaborations) • 59 pages • 2024
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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 ...
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US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified)
- Exam (elaborations) • 38 pages • 2023
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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...
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US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers)
- Exam (elaborations) • 38 pages • 2023
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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...
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US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution.
- Exam (elaborations) • 15 pages • 2024
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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 Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers)
- Exam (elaborations) • 38 pages • 2023
-
- $14.99
- + learn more
US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers). 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, fat...
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RAC Questions And Answers 2023
- Exam (elaborations) • 23 pages • 2023
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When is an NDA annual report due? - ANS-60 days after the anniversary date of U.S. approval of the 
application. NDA 
Reporting Period ? All Blood and HCT/P Problems - ANS-45 calendar days of Fatal/Life 
threateneing/Disabling/Surgical Intervention and hospitalization 
Reporting Period? Postmarket Device Death, Serious Injury, Malfunction - ANS-Within 30 calendar days 
of awareness 
Reporting Period? Device Special FDA, or Remedial Action to Prevent Death/Harm - ANS-Within 5 work 
days of aw...
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US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution.
- Exam (elaborations) • 15 pages • 2024
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- $12.99
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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...
-
Sterile Processing Progress Test 2 IAHCSMM CRCST Accurate 100%
- Exam (elaborations) • 3 pages • 2023
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Class II 
Biological indicators are too. - ANSWER Chemical indicators are FDA ____ Devices 
 
They harbor bacteria - ANSWER Watches and other jewelry should NOT be worn in the Central Service department work areas because: 
 
De-ionization 
Process of ions being removed from water with an electrical charge - ANSWER System used to treat the final rinse water used for cleaning is: 
 
FDA 
regulates: 
Registration and listing 
medical device reporting, tracking, corrections, and removals 
quality ...
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US RAC Questions With Complete Solutions Latest Update 2024 (100% Verified Answers)
- Exam (elaborations) • 38 pages • 2024
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- $15.49
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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...
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IAHCSMM practice exam Correct 100%
- Exam (elaborations) • 3 pages • 2023
- Available in package deal
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- $9.99
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T or F - All medical terms consist of each of the following word elements: prefix, root and suffix. - ANSWER FALSE 
 
T or F - There are two parts to the ear: the outer ear and the inner ear. - ANSWER FALSE 
 
T or F - Cells are the basic units of all living organisms and are the smallest element that can live, grow and reproduce. - ANSWER TRUE 
 
What type of bacteria develops spores? - ANSWER gram-positive AND gram-negative 
 
What percentage of microorganisms are harmful to humans because the...
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