US RAC: Chapter 14 Exam Questions and Answers with Verified
Solutions | Latest 2026 Update
Q: Drug Price Competition and Patent Term Restoration Act of 1984
(Hatch-Waxman Act)
Answer:
amended the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) to create
the contemporary Abbreviated New Drug Application (ANDA) generic drug
approval process under Section 505(j)
Q: ANDA statutory provisions state that...
Answer:
an application containing bioequivalence data to a Reference Listed Drug (RLD),
among other data and information, is sufficient for FDA to consider approval
Q: As part of the Hatch-Waxman Act compromise, brand-name drug companies
may...
Answer:
obtain a patent term extension for time lost during the regulatory review period,
can submit to FDA for listing certain types of patents in the Orange Book, and may
also be eligible for a period of non-patent exclusivity
Q: Orphan Drug Act
Answer:
rewards sponsors for developing products to treat rare diseases and conditions
Q: Best Pharmaceuticals for Children Act (BPCA)
Answer:
rewards sponsors for developing products for cihldren
Q: Title II of the Hatch-Waxman Act
Answer:
certain patents related to products regulated by FDA are eligible for extension if
patent life was lost during a period of regulatory review
Q: Regulatory Review Period
, Answer:
composed of testing phase and review phase
Q: Testing Phase (for a drug product)
Answer:
begins on the effective date of a Investigational New Drug Application (IND) and
ends on the date a New Drug Application (NDA) is submitted to FDA
Q: Review Phase (for a drug product)
Answer:
period between submission and approval of a New Drug Application (NDA)
Q: A patent term may be extended...
Answer:
for a period of time that is the sum of one-half of the time in the testing phase, plus
all the time in the review phase
Q: An extended patent term may not exceed...
Answer:
14 years after the date of approval of the marketing application
Q: A drug patent may be extended if...
Answer:
- the term of the patent has not expired
the patent has not been previously extended
the extension application is submitted by the owner of record within 60 days of
NDA approval
the product, use, or method of manufacturing claimed has been subject to a
regulatory review period before it is commercially marketed, and
the NDA is the first permitted commercial use of the drug product
Q: Interim Patent Extension
Answer:
1) those available during the review phase of the statutory regulatory review period
2) those available during the PTO's review of an application for patent term
extension
Solutions | Latest 2026 Update
Q: Drug Price Competition and Patent Term Restoration Act of 1984
(Hatch-Waxman Act)
Answer:
amended the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) to create
the contemporary Abbreviated New Drug Application (ANDA) generic drug
approval process under Section 505(j)
Q: ANDA statutory provisions state that...
Answer:
an application containing bioequivalence data to a Reference Listed Drug (RLD),
among other data and information, is sufficient for FDA to consider approval
Q: As part of the Hatch-Waxman Act compromise, brand-name drug companies
may...
Answer:
obtain a patent term extension for time lost during the regulatory review period,
can submit to FDA for listing certain types of patents in the Orange Book, and may
also be eligible for a period of non-patent exclusivity
Q: Orphan Drug Act
Answer:
rewards sponsors for developing products to treat rare diseases and conditions
Q: Best Pharmaceuticals for Children Act (BPCA)
Answer:
rewards sponsors for developing products for cihldren
Q: Title II of the Hatch-Waxman Act
Answer:
certain patents related to products regulated by FDA are eligible for extension if
patent life was lost during a period of regulatory review
Q: Regulatory Review Period
, Answer:
composed of testing phase and review phase
Q: Testing Phase (for a drug product)
Answer:
begins on the effective date of a Investigational New Drug Application (IND) and
ends on the date a New Drug Application (NDA) is submitted to FDA
Q: Review Phase (for a drug product)
Answer:
period between submission and approval of a New Drug Application (NDA)
Q: A patent term may be extended...
Answer:
for a period of time that is the sum of one-half of the time in the testing phase, plus
all the time in the review phase
Q: An extended patent term may not exceed...
Answer:
14 years after the date of approval of the marketing application
Q: A drug patent may be extended if...
Answer:
- the term of the patent has not expired
the patent has not been previously extended
the extension application is submitted by the owner of record within 60 days of
NDA approval
the product, use, or method of manufacturing claimed has been subject to a
regulatory review period before it is commercially marketed, and
the NDA is the first permitted commercial use of the drug product
Q: Interim Patent Extension
Answer:
1) those available during the review phase of the statutory regulatory review period
2) those available during the PTO's review of an application for patent term
extension
