FDA division covering biologics A) CDER. B) CBER C) CMER. D) CDRH FDA division c
ID: 84122 • Letter: F
Question
FDA division covering biologics A) CDER. B) CBER C) CMER. D) CDRH FDA division covering medicines A) CDER. B) CBER. C) CMER. D) CDRH A Phase II trial looks at A) Safety B) Efficacy C) Diverse patient population D) All of the above A Phase I/II trial is usually reserved for therapeutics that are: A) Already approved in China B) Have a NDA C) Received a Black Box warning D) Vaccines or Prophylactics A promising drug from testing that is shown to be safe in animals may move to human testing after submission of a(n) _______ to the FDA? A) IND B) NDA. C) Patent Board D) IRB done using humans: A panel of physicians, scientists, & lay persons who oversee research done using humans: A) IND B) NDA. C) Patent Board D) IRBExplanation / Answer
22. Answer B- CBER- Center for biologics evaluation and research.
23. Answer A- CDER- Center for drug evaluations and research
24. Answer D- A phase 2 trial considers evaluating safety, efficacy and diversity of the population under the study.
25. Answer D- vaccines or prophylactics.
26. Answer A- IND- Investigational drug application
27.Answer D - IRB- Institutional review board
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