Podcast
Questions and Answers
What type of drug products are coded with 'B' codes?
What type of drug products are coded with 'B' codes?
- Therapeutically equivalent products
- Products that are under regulatory review
- Products that are approved by the state
- Products that are not therapeutically equivalent to other pharmaceutically equivalent products (correct)
What is a common misconception about generic drugs?
What is a common misconception about generic drugs?
- They are not FDA-approved
- They are more expensive than brand-name drugs
- They are not as potent as brand-name drugs (correct)
- They are only available for certain diseases
What is the main purpose of product substitution?
What is the main purpose of product substitution?
- To promote brand-name drugs
- To ensure therapeutic equivalence (correct)
- To bypass FDA approval process
- To reduce the cost of drug products
What is a benefit of generic substitution?
What is a benefit of generic substitution?
According to the FDA, which type of products have documented bioequivalence problems?
According to the FDA, which type of products have documented bioequivalence problems?
What type of drugs may not be suitable for generic substitution?
What type of drugs may not be suitable for generic substitution?
What is the main factor considered by insurance providers when deciding on formularies?
What is the main factor considered by insurance providers when deciding on formularies?
What is the main purpose of the FDA guidance on therapeutic equivalence?
What is the main purpose of the FDA guidance on therapeutic equivalence?
What is required before a pharmacy can request a generic substitution in Iowa?
What is required before a pharmacy can request a generic substitution in Iowa?
What is the main consideration for professionals when deciding on drug products?
What is the main consideration for professionals when deciding on drug products?
What phase of drug development is specific to brand-name products?
What phase of drug development is specific to brand-name products?
What is a major difference between brand-name drugs and generic drugs?
What is a major difference between brand-name drugs and generic drugs?
What is a requirement for a generic product to gain FDA approval?
What is a requirement for a generic product to gain FDA approval?
What is therapeutic equivalence (TE) based on?
What is therapeutic equivalence (TE) based on?
What is the purpose of FDA's Orange Book list?
What is the purpose of FDA's Orange Book list?
What does an 'AB' code indicate?
What does an 'AB' code indicate?
What is the assumption of therapeutic equivalence (TE) products?
What is the assumption of therapeutic equivalence (TE) products?
What is bioequivalence (BE) evaluation based on?
What is bioequivalence (BE) evaluation based on?
