Rac chapter 1 fda - Study guides, Class notes & Summaries
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RAC Chapter 1 - FDA and related regulatory agencies Exam Questions and Answers
- Exam (elaborations) • 2 pages • 2024
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RAC Chapter 1 - FDA and related regulatory agencies Exam Questions and Answers
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RAC Chapter 18N (15)- OTC Drug Products Questions And Answers
- Exam (elaborations) • 6 pages • 2023
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RAC Chapter 18N (15)- OTC Drug Products Questions And Answers 
In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) 
established what three criteria that would limit a drug to prescription status: - ANS-• habit forming 
drugs 
• not safe for use unless supervised by a healthcare 
professional 
• limited to prescription use under a New Drug 
Application (NDA) 
What are the typical characteristics for OTC drugs? - ANS-• benefits clearly outweigh pos...
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FDA Adverse Event Reporting - RAC US
- Exam (elaborations) • 4 pages • 2023
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FDA Adverse Event Reporting - RAC US 
5 day Report - ANS->803.53 (Device) 
5 work days after the day that you become aware that: 
(a) An MEDICAL DEVICE REPORTING (MDR) reportable event necessitates remedial action to prevent an 
unreasonable risk of substantial harm to the public health. You may become aware of the need for 
remedial action from any information, including any trend analysis; or 
(b) We (The FDA) have made a written request for the submission of a 5-day report. If you recei...
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RAC- chapter 3 Questions and Answers
- Exam (elaborations) • 10 pages • 2023
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Decision Tree - Answer-1.Drug,Device or Some Combination - For human use -drug - new drug = New NDA Route 505(b)(1) 
2.Drug,Device or Some Combination- For human use -drug- NOT new drug- same formulation as RLD=ANDA Route 
3. Drug,Device or Some Combination- For human use -drug- not new drug- NOT same formulation as RLD- Right of reference to original NDA=NDA Supplement ( same formulation, new indication, new route) 
4. Drug,Device or Some Combination- For human use -drug- not new drug- NOT sa...
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RAC Chapter 1 - FDA and related regulatory agencies Exam Questions and Answers
- Exam (elaborations) • 2 pages • 2023
- Available in package deal
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FDA is under? - Answer-Department of health and human services (DHHS) 
 
FDA regulates what types of products? - Answer-Food, dietary supplements, cosmetics, vet products, drugs, med devices, biologics, tobacco, vaping 
 
Statute vs regulation vs Guidance - Answer-Statute is a law passed by congress, regulation is a rule issued by a federal agency, guidance is the FDA's current thinking on its regulations 
 
Biologics control act - Answer-1901 law regulating vaccines, serums and antibodies 
 
F...
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