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WORLD OF GENERIC DRUGS MODULE

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Generic Drugs Overview

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Under which act was an abbreviated mechanism for generic drug approvals created?
- The Collins-Edwards Act of 1994.
- The Romney-Benson Act of 1992.
- The Hatch-Waxman Act of 1984.
- The Bachmann-Turner Act of 1974.
What is meant by the term "orphan drug"?
- An orphan drug is a product that treats a rare disease that affects fewer than 200,000 people.
- An orphan drug is a product whose patent has expired.
- An orphan drug is a product whose active pharmaceutical ingredient(s) are no longer manufactured.
- An orphan drug is a product under review that may not be prescribed.
For what purpose does the FDA send inspectors to conduct bioequivalence measures?
- To ensure that brand name drugs treating similar symptoms can be differentiated.
- To ensure that generic drugs are less expensive than their brand name counterparts.
- To determine whether additional generic drugs should be made available to the public.
- To ensure that a brand name drug and its generic counterpart match one another.
How often are periodic adverse drug experience reports mandated by the FDA for the first three years following approval?
- Every six weeks.
- Quarterly.
- Semi-annually.
- Annually.
Which of the following actions can the Therapeutic Inequivalency Action Coordinating Committee take with regard to regulatory action?
- Remove inequivalent products from the market.
- Recommend a grandfathered product submit a new drug application.
- Evaluate the toxicity profile of injectables and mandate appropriate controls.
- All of the above.
More than half of all generic products on the market are corporately tied to brand companies.
- True.
- False.

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