6: Regulation in Biotechnology
Students review FDA history, clinical trial phases, the Asilomar Conference, the Coordinated Framework, biotech patents, CRISPR patent disputes, and drug regulation.
Clinical Trial Phases from Descriptions
Click to show Clinical Trial Phases from Descriptions example problem
Note: Each choice will be used exactly once.
| Your Choice | Prompt | |
|---|---|---|
| 1. Phase 3 | ||
| 2. Phase 4 | ||
| 3. Phase 0 | ||
| 4. Phase 2 | ||
| 5. Phase 1 |
Drag one of the choices below:
- A. Compare the drug with other treatments while continuing to monitor side effects
- B. Patients who are already taking the approved drug
- C. Test whether the drug is effective against the disease and record its side effects
- D. Altruistic volunteers who accept an invasive study that offers no treatment benefit
- E. Healthy volunteers, or terminally ill volunteers when healthy people should avoid the drug
Types of Intellectual Property from Descriptions
Click to show Types of Intellectual Property from Descriptions example problem
Note: Each choice will be used exactly once.
| Your Choice | Prompt | |
|---|---|---|
| 1. Patent | ||
| 2. Trademark | ||
| 3. Copyleft | ||
| 4. Copyright |
Drag one of the choices below:
- A. protects a brand name or logo that identifies the source of a product
- B. gives its owner the exclusive right to exclude others from making an invention
- C. gives its owner the exclusive right to make copies of a creative work, usually for a limited time
- D. requires that modified versions of a free work stay free for others to use
Federal Agency Roles in Transgenic Crop Regulation
Click to show Federal Agency Roles in Transgenic Crop Regulation example problem
Note: Each choice will be used exactly once.
| Your Choice | Prompt | |
|---|---|---|
| 1. Environmental Protection Agency (EPA) | ||
| 2. Food and Drug Administration (FDA) | ||
| 3. Health Inspection Service of the U.S. Department of Agriculture (USDA) | ||
| 4. National Institute of Health (NIH) |
Drag one of the choices below:
- A. Writes the guidelines that limit how a transgenic crop is constructed and grown.
- B. Assesses the environmental effect of a transgenic crop on the animals around the farm.
- C. Reviews the safety of food made from a transgenic crop before people eat it.
- D. Grants the permit for an outdoor field trial of a transgenic crop.
Patentable Inventions Versus Scientific Discoveries
Click to show Patentable Inventions Versus Scientific Discoveries example problem
Clinical Trial Phases from Study Descriptions
Click to show Clinical Trial Phases from Study Descriptions example problem
Which one of the following clinical-trial phases correspond to the description 'A few hundred randomized patients chosen with strict eligibility rules'.
Types of Intellectual Property from Descriptions
Click to show Types of Intellectual Property from Descriptions example problem
Which one of the following types of intellectual property correspond to the description 'lets the inventor stop others from making, using, or selling the invention'.
Federal Agencies by Transgenic Crop Regulatory Responsibility
Click to show Federal Agencies by Transgenic Crop Regulatory Responsibility example problem
Which one of the following federal agencies correspond to the regulatory job 'Checks whether a transgenic crop harms insects or other animals living in the field.'.