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OFFICE OF NEW DRUGS MODULE
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Biologics Review
Learning Objectives
Introduction
Quality Review - Biologics
Biological Products - Larger, Complex and Diverse
Unique Characteristics
CDER-Regulated Biologics
New Drug Applications (NDA) vs. Biologics License Applications (BLA)
Licensing a Biologic
BLA Approvals
Knowledge Check
Certificate of Completion
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Knowledge Check
Which of the following does not fall within the definition of a biological product?
Vegetable extract
Virus
Vaccine
Toxin and antitoxin
What is understood by the term "comparability" as used by FDA?
It defines the applicable parameters relating to drug scalability.
It is a table of molecular equivalencies for determining the meta-identity of drugs.
It refers to the comparison of a biological product before and after a manufacturing change.
It establishes a sequence of cross-referential indices used in the approval process.
Which is the best description of the term Sulfation?
A sulfonate combines with protein to form a sulfonoprotein.
The transfer of a sulfonate to a protein.
The directed degradation of sulfonate.
A hydrogen atom in an organic compound is replaced by a sulfonyl group.
Which of the following is not a similarity between a new drug application and biologics license application?
Both have a fast-track designation.
Both require financial disclosure.
Both have pediatric study requirements.
Both obtain their regulatory power from the Public Health Service Act.
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