Patricia Kerby, MPA Human Subjections Protection Compliance Officer Office of Research Compliance

1. What are the FDA’s expectations in 2010? Patricia Kerby, MPAHuman Subjections Protection Compliance OfficerOffice of Research Compliance

2. Though no one can go back and make a brand new start, anyone can start from now and make a brand new ending. Anonymous

3. “The best predictor for future behavior is past behavior.” (paraphrased) Dr. Phil

4. The form detailing Findings and Observations from a FDA Inspection is known as which form number? • 438 • 483 • 1571 • 1572

5. The FDA Form entitled Investigational New Drug Application is which number? • 1571 • 1572 • 2001/20 • 93/41

6. Which FDA Form includes the following statements:I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects. • 1571 • 1572 • 483 • Investigator Agreement

7. If you received an FDA Form 482 what would this notify you of? • Being suspended from taking part in clinical trials • A Critical Inspection Finding requiring immediate response • A forthcoming FDA Inspection • A debarment notice

8. If you had completed and submitted an FDA Form 356h what would you be doing? • Applying for Orphan Drug Status • Applying for IND status • Applying to market new drug • Applying to have an end of Phase II meeting with the FDA

9. Source for quiz • http://www.pharmaschool.org/ukgcp03.asp?testtitle=pst251&title=Clinical%20Research%20Forms

10. History of the FDA The FDA has a colorful history, and celebrated its 100th anniversary in 2006. Began as the Division of Chemistry in 1867 then in July 1901 became the Bureau of Chemistry, the modern day era of the FDA dates to 1906 with the passage of the Food and Drugs Act. The unsanitary conditions of the meat packing industry that Upton Sinclair wrote about in The Jungle prompted this legislation.

11. History continued Food, Drug, and Cosmetic Act June 1938 The Division of Biologics control began in 1955 after 260 cases of polio occurred after receiving the polio vaccine In 1964 Congress passed the Kefauver-Harris amendments to ensure drug efficacy and greater drug safety The most recent legislation was the Food and Drug Administration Amendment Act of 2007, or FDAAA.

12. The Office of Bioresearch Monitoring Most human medical products including biologics, drugs and devices are regulated by three FDA centers. • The Center for Biologics Evaluation and Research (CBER) • The Center for Drug Evaluation and Research (CDER) • The Center for Devices and Radiological Health (CDRH)

13. 5 Top Inspectional Observations • An investigation was not conducted in accordance with the signed statement of investigator or investigational plan ( 21 CFR 312.60) • Failure to prepare or maintain adequate or accurate case histories with respect to observations and data pertinent to the investigation or informed consent (21 CFR 312.62(b)

14. Top Observations Continued • Failure to obtain informed consent, in accordance with 21 CFR Part 50, from each human subject prior to drug administration or conducting study related tests. (21 CFR 312.60) • Investigational drug disposition records are not adequate with respect to dates, quantity or use by subjects (21 CFR 312.62(a)) • Failure to promptly report to the IRB all unanticipated problems involving risk to human subjects or others. (21 CFR 312. 60)

15. Group Time • List what steps you would take to answer the issues stated.

16. The FDA 483 cited the following: An unexpected adverse device effect for study ABC was not reported to the Sponsor and IRB within 10 working days after receiving knowledge of the event. • The clinical investigator provided the following response: • “Due to an oversight, a UADE for this study was not reported to the sponsor and the IRB within 10 working days of receiving knowledge of the event. As a corrective and preventive action, we have implemented a written procedure to ensure that all UADEs will be reported within 10 working days. All study staff have already been trained on this new procedure. Copies of this procedure and associated training records are attached. We have also reviewed adverse events for our other studies and concluded that this issue was an isolated event. Within 6 months, we will conduct an audit of all adverse events to determine if this corrective action was effective.”

17. http://www.fda.gov/Training/CDRHLearn/ucm180878.htm