Question 1

Distinguish between utility, design, and plant patents.

Accepted Answer

Utility patents protect processes, machines, and manufactured goods, such as computer hardware and medicines.
Design patents protect against the unauthorized use of new or original designs for manufactured goods. An example would be the look of a bike helmet or shoe.
Plant patents protect invented or discovered asexually produced plant varieties.

Question 2

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?

Accepted Answer

A)  True 
B)  False 
A)  True 
B)  False B

Question 3

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

Accepted Answer

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

Question 4

Describe what the FDA, EPA, and USDA oversee.

Accepted Answer

The Food and Drug Administration oversee

Question 5

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.

Accepted Answer

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

Question 6

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

Accepted Answer

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

Question 7

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

Accepted Answer

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 
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 8

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

Accepted Answer

A)  National Institutes of Health 
B)  U.S. Department of Agriculture 
C)  Environmental Protection Agency 
D)  Food and Drug Administration 
E)  National Science Foundation 
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 9

Viral resistance in crops would be regulated by which agency?

Accepted Answer

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

Question 10

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

Accepted Answer

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

Question 11

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

Accepted Answer

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

Question 12

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.

Accepted Answer

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

Question 13

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

Accepted Answer

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 
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 14

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

Accepted Answer

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

Question 15

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

Accepted Answer

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

Question 16

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.

Accepted Answer

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 
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 17

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

Accepted Answer

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

Question 18

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

Accepted Answer

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

Question 19

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

Accepted Answer

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

Question 20

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

Accepted Answer

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

Distinguish between utility, design, and plant patents.

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?

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

Describe what the FDA, EPA, and USDA oversee.

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.

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

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

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

Viral resistance in crops would be regulated by which agency?

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

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

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.

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

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

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

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.

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

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

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

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

The Biotechnology Century and Its Workforce

An Introduction to Genes and Genomes

Recombinant Dna Technology and Genomics

Proteins As Products

Microbial Biotechnology

Plant Biotechnology

Animal Biotechnology

Dna Fingerprinting and Forensic Analysis

Bioremediation

Aquatic Biotechnology

Medical Biotechnology

Ethics and Biotechnology

Filters

Exam 12: Biotechnology Regulations

Distinguish between utility, design, and plant patents.

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?

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

Describe what the FDA, EPA, and USDA oversee.

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.

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

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

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

Viral resistance in crops would be regulated by which agency?

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

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

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.

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

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

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

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.

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

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

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

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

The Biotechnology Century and Its Workforce

An Introduction to Genes and Genomes

Recombinant Dna Technology and Genomics

Proteins As Products

Microbial Biotechnology

Plant Biotechnology

Animal Biotechnology

Dna Fingerprinting and Forensic Analysis

Bioremediation

Aquatic Biotechnology

Medical Biotechnology

Ethics and Biotechnology

Filters