P. Below Consulting - FDA Inspections of Invesitgator Sites MAGI 2008

Clinical Research Services for the Pharmaceutical and Medical Device Industries

Presented to:

MAGI 2008 Clinical Trial Agreements, Budgets & Regulatory Conference EAST
Arlington, Virginia
May 20, 2008

FDA Inspections of Investigator Sites

Presentation:

References:

Compliance Program Guidance Manual for Clinical Investigators (7348.811) at www.fda.gov/ora/compliance_ref/bimo/7348_810/48-810.pdf
Warning Letters available on the FDA website at www.fda.gov/foi/warning.htm
Some 483s (sponsor and IRB) available at www.fda.gov/ora/frequent/default.htm
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters atwww.fda.gov/foi/nidpoe/default.html
Clinical Investigator Inspection List available at www.fda.gov/cder/regulatory/investigators/default.htm
A Handbook for Requesting Information and Records from FDA available at www.fda.gov/opacom/backgrounders/foiahand.html
"For-cause CI inspections dropped to 58 in FY '06, complaints on the rise, officials told" article published on Entrepreneur.com
"For Cause" Inspections Find Galloping Clinical Trial Violation Rate" article published on Medical Devices Today