Deck 12: Biotechnology Regulations

Question 1

Which agency would be in charge of determining whether or not modified oil content is safe to eat?

A) FDA
B) USDA
C) EPA
D) USPTO
E) None of these choices

Answer 1

A

Question 2

Following successful completion of a phase III trial for a particular drug, a biotechnology company would apply for a(an) ________ to receive approval to sell the drug.

A) IND
B) DNA
C) NDA
D) patent
E) copyright

Answer 2

C

Question 3

Phase ________ trials occur when a drug is tested on several thousand people to determine its effectiveness compared to current drugs on the market.

A) I
B) II
C) III
D) IV
E) V

Answer 3

C

Question 4

________ needs to be approved before testing a new drug in humans.

A) An NDA
B) An IND
C) An FDA
D) A CDE
E) An EPA

Question 5

Which of the following regulatory agencies is charged with the regulation of plant pests and plants?

A) USDA
B) IND
C) EPA
D) FDA
E) USPTO

Question 6

Is it true or false that the generally-recognized-as-safe rule means that the FDA sees a foreseeable threat from human use of the product?

A) True
B) False

Question 7

A ________ provides an inventor with government-granted protection of an invention for a period of time, preventing others from using or making the invention without being licensed to do so.

A) clinical trial
B) NDA
C) patent
D) royalty
E) licensing agreement

Question 8

________ is/are quality control regulations that govern procedures for human subject experimentation.

A) Good clinical practices (GCPs)
B) Quality assurance (QA)
C) Preclinical testing
D) Good laboratory practices (GLPs)
E) Good manufacturing practices (GMPs)

Question 9

Which U.S. regulatory agency oversees guidelines and laws that govern environmental applications of biotechnology and other sciences?

A) USDA
B) EPA
C) FDA
D) NIH
E) NSF

Question 10

The ________ is the federal agency that provides a majority of federal funding for medical research in the United States and oversees all federally funded medical research in the United States.

A) Food and Drug Administration
B) National Institutes of Health
C) Environmental Protection Agency
D) U.S. Department of Agriculture
E) Department of Environmental Protection

Question 11

Which agency determines whether or not something is safe for the environment?

A) FDA
B) USDA
C) EPA
D) USPTO
E) None of these choices

Question 12

Which federal agency oversees, regulates, and monitors the safety of biotech and pharmaceutical products and medical devices during consumer use?

A) National Institutes of Health
B) U.S. Department of Agriculture
C) Environmental Protection Agency
D) Food and Drug Administration
E) National Science Foundation

Question 13

Phase ________ trials occur when a drug is tested on individuals with a disease to determine the effectiveness of a drug in treating a disease.

A) I
B) II
C) III
D) IV
E) V

Question 14

Phase ________ trials occur when a drug is tested on small groups of healthy individuals to determine the proper dose and route of administration.

A) I
B) II
C) III
D) IV
E) V

Question 15

Viral resistance in crops would be regulated by which agency?

A) FDA
B) USDA
C) EPA
D) USPTO
E) None of these choices

Question 16

A patent for a DNA sequence would be deemed to have substantive utility if it ________.

A) showed what the DNA sequence coded for
B) showed a real-world use for the DNA sequence
C) showed the nucleotide sequence of the DNA
D) showed the protein sequence of the DNA
E) showed that the DNA sequence was found in other organisms

Question 17

If you were developing a transgenic strain of pest-resistant watermelons, which federal agency would primarily be responsible for regulating this biotech product?

A) FDA
B) DEP
C) USDA
D) EPA
E) DOT

Question 18

The government regulations that are required for making of a biologic medicine is known as ________.

A) GCP
B) GLP
C) GMP
D) QA
E) QC

Question 19

Which of the following U.S. agencies oversees phase testing of drugs prior to their approval for clinical uses?

A) USDA
B) EPA
C) FDA
D) NIH
E) NSF

Question 20

An average time range necessary for completing phase testing of drugs during clinical trials is approximately ________.

A) 6 months to 1 year
B) 1 to 3 years
C) 2 to 4 years
D) 5 to 8 years
E) 8 to 12 years

Question 21

Describe what is measured during the first three phases of clinical trials.

Question 22

Distinguish between utility, design, and plant patents.

Question 23

Describe what the FDA, EPA, and USDA oversee.