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Posttest for The FDA & Stem Cells: Understanding Stem Cells & The Clinical Trial Process – Expectations and Concerns of the FDA

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Name*
First Last
Email*

The FDA is part of the:*
- A. State government
- B. A division of the AMA
- C. Part of the CDC
- D. Part of the Federal government
What is the goal of the FDA*
- A. To protect public health
- B. To hinder progress for live-saving cures
- C. To make money
- D. To create jobs
Stem cells derived from adipose tissue are:*
- A. Not regulated by the FDA
- B. Regulated by the state medical board
- C. Products that do not require premarket authorization
- D. Regulated as biologic products requiring licensure
Information provided by guidance should generally be taken as*
- A. Laws that must be obeyed
- B. Regulations that must be followed
- C. Absolute requirements for regulatory compliance
- D. Recommendations that help stay in compliance with the regulations
The investigation of stem cell products generally should proceed under:*
- A. An protocol approved by an institutional review board
- B. A protocol approved by the American Association of Tissue Banks
- C. An active investigational new drug application
- D. A and C
A stem cell product addressing a serious or life-threatening condition is eligible for which of the following expedited development programs*
- A. Fast track designation
- B. Priority review
- C. Accelerated approval
- D. Breakthrough therapy designation
- E. Regenerative medicine advanced therapy designation
- F. All of the above

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