FDA Legislation and Regulations

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What was the primary focus of the 1962 Kefauver-Harris Amendments?

Promoting drug price competition

Establishing the FDA

Encouraging pharmaceutical innovation

Ensuring products are safe and effective (correct)

What is the term for pharmaceutical products that have the same drug, dosage form, route of administration, and strength?

Pharmaceutical equivalence (correct)

Generic equivalence

Therapeutic equivalence

Bioequivalence

According to the FDA's bioequivalence range, what is the acceptable percentage range for Cmax and AUC?

80-125% (correct)

90-110%

70-130%

80-120%

What is the primary reason for generic prescription substitution?

To lower the cost of prescription drugs Signup and view all the answers

What is the requirement for pharmacies in Iowa before substituting a lower-priced generic or TE drug for a higher-priced prescribed drug?

Obtaining approval from the provider prior to requesting substitution Signup and view all the answers

What is the primary purpose of the FDA's Orange Book List?

To list approved drug products with therapeutic equivalence evaluations based on safety and efficacy Signup and view all the answers

What does an 'AB' code indicate on the FDA's Orange Book List?

The test product and RLD/RS are therapeutically equivalent and bioequivalent Signup and view all the answers

What type of drugs may not be appropriate for substitution with generic subs?

Hormones and drugs with a narrow therapeutic ratio and critical dose Signup and view all the answers

What does the 'B' code category on the FDA's Orange Book List refer to?

Drugs with specific formulation or delivery system issues Signup and view all the answers

What is the purpose of the TE codes on the FDA's Orange Book List?

To determine products that are therapeutically equivalent to each other Signup and view all the answers

FDA Legislation and Regulations

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Questions and Answers

What was the primary focus of the 1962 Kefauver-Harris Amendments?

What is the term for pharmaceutical products that have the same drug, dosage form, route of administration, and strength?

According to the FDA's bioequivalence range, what is the acceptable percentage range for Cmax and AUC?

What is the primary reason for generic prescription substitution?

What is the requirement for pharmacies in Iowa before substituting a lower-priced generic or TE drug for a higher-priced prescribed drug?

What is the primary purpose of the FDA's Orange Book List?

What does an 'AB' code indicate on the FDA's Orange Book List?

What type of drugs may not be appropriate for substitution with generic subs?

What does the 'B' code category on the FDA's Orange Book List refer to?

What is the purpose of the TE codes on the FDA's Orange Book List?

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