FDA Clinical Trial Requirements – Regulations, Compliance, and GCP - 5/17-18/2006

The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions (PDF)
http://www.fda.gov/cber/summaries/socra051706ph1.pdf

The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions (Text) - Patricia Holobaugh
http://www.fda.gov/cber/summaries/socra051706ph1.htm

Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials (PDF)
http://www.fda.gov/cber/summaries/socra051706ph2.pdf

Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials (Text) - Patricia Holobaugh
http://www.fda.gov/cber/summaries/socra051706ph2.htm