OFFICE OF NEW DRUGS MODULE

Knowledge Check

Which of the following is not contained in the FDA adaptation of the guidelines based on the general principles of ICH E-11?
- Pediatric studies present significant ethical concerns and increased liability risk for drug manufacturers.
- Pediatric patients should be given medicines that have been properly evaluated for use in the pediatric population.
- Product development programs should include pediatric studies when appropriate.
- Pediatric product development should not delay adult studies or the availability of drugs for adult patient.
Which of the following does not apply to the Best Pharmaceuticals for Children Act?
- It provides a financial incentive to pharmaceutical companies to test drugs with remaining patent life in pediatric patients.
- It creates a process by which FDA and the National Institutes of Health can partner to obtain studies of off-patent drugs in pediatric patients.
- It requires pharmaceutical companies to assess the safety and effectiveness of new drug and biologic products in pediatric patients.
The Pediatric Research Equity Act authorizes the FDA to require a pediatric assessment of the safety and effectiveness of a drug or biologic for the claimed indications in all relevant pediatric subpopulations.
- True
- False

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