Edward M. Basile

Clinical Investigator Responsibilities -- Protecting the Rights, Safety and Welfare of Study Subjects
Edward M. Basile, Beverly Lorell, Christina M. Markus, Elaine H. Tseng, November 6, 2009
The Food and Drug Administration (FDA) posted a final guidance in October 2009 to clarify the responsibilities of investigators in conducting clinical trials of drugs, biological products and medical devices. The final guidance reiterates the scope of responsibilities set forth in a May 2007 draft...

FDA Holds Second Transparency Task Force Public Meeting Including Issues Related to Disclosure of Clinical Trial Data
Edward M. Basile, Daniel Francis Donovan, Beverly Lorell, Seth H. Lundy, Jessica Ringel, November 6, 2009
On November 3, the U.S. Food and Drug Administration's (FDA or Agency) Transparency Task Force held its second public meeting. Principal Deputy Commissioner and Task Force leader Joshua Sharfstein stated that the Task Force's goal is to draft recommendations for FDA Commissioner Margaret Hamburg...

Subcommittee on Health Examines Medical Device Safety
Edward M. Basile, Daniel Francis Donovan, Theodore M. Hester, Marian Lee, Beverly Lorell, July 1, 2009
On June 18, 2009, the Subcommittee on Health of the House Committee on Energy and Commerce held a hearing to examine whether the current processes for medical device approval sufficiently protected users of medical devices.