In Order for a Drug to Be Approved by the FDA

question 8

Multiple Choice

In order for a drug to be approved by the FDA as a generic equivalent, which of the following must be true?

• A)It must vary less than 50 percent from the comparison drug.
• B)It must vary less than 20 percent from the comparison drug.
• C)It must vary less than 75 percent from the comparison drug.
• D)It must vary less than 30 percent from the comparison drug.

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Definitions:

Introns

Introns are non-coding sequences within a gene that are removed by RNA splicing during maturation of the final mRNA molecule.

Mature mRNA

The final form of messenger RNA (mRNA) after processing, ready for translation into a protein in the cytoplasm.

Reverse Transcriptase

An enzyme that catalyzes the formation of DNA from an RNA template, a process central to the replication of retroviruses.

Recombinant Plasmids

Engineered DNA molecules formed by inserting a fragment of DNA into a plasmid vector, used in genetic engineering and biotechnology.