The requirements of the pediatric research equity act

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Reference no: EM132202251

True or False with Explanation(a sentence or two)

1. True or False: FDA’s BIMO program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

2. True or False: The requirements of the Pediatric Research Equity Act (PREA) only apply to Drug products, and can not be deferred or waived.

3. True or False: The European Union (EU) Directive uses the same definition for “investigational new drug” (21 CFR 312.2(b)) and “investigational device” (21 CFR 812.3(g)) as FDA.

4. True or False: One statutory difference between Drugs and Devices is that Devices lack market exclusivity provisions.

5. True or False: FDA currently enforces all the provisions found in 21 CFR Part 11, which govern both Electronic Records & Electronic Signatures.

6. True or False: For approved NDAs, under 21 CFR 314.80 and 314.81, FDA requires Postmarketing Reporting of Adverse Drug Experiences and Other Postmarketing Reports, respectively.

7. True or False: FDA’s August 2013 Guidance titled Oversight of Clinical Investigations - A Risk Based Approach to Monitoringcomplements the theme of “high quality data” being defined as the absence of errors that matter.

Reference no: EM132202251

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