Articles from BioResearch Compliance Report (September 1, 2006)

Title	Author	Type	Words
BiMo inspection FOIA log.			190
FDA releases SFBC 483s, citing case histories, inadequate investigations and protocol violations.			928
FDA working with CDISC to develop standards for electronic data exchange: woodcock.	Pickett, Joseph		648
Investigator warning letters on track for 30 in 2006; IRB letters focus mostly on inadequate membership.	Pickett, Joseph		745
IRB determination letters.			110
OHRP investigator says IRB staff must know all rules, including Subparts B, C and D.	Pickett, Joseph		364
Patient harm not key in prosecutions, U.S. attorney says.	Cezanne, Jeannette		668
Subpart E should be added to OHRP rules to protect subjects with diminished cognitive skills: SACHRP.			361
Warning letters.			1778