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The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals

USA - May 26 2016 Last week, the U.S. Department of Health and Human Services ("HHS") announced that FDA intends to update its regulations governing clinical studies…

Will Sad Facts Make Bad Law?

USA - May 23 2016 Despite popular opinion, lawyers and judges are human and sometimes the facts of a case make it near impossible for judges to play the role of the…

NIH issues proposed rule expanding clinical trial registration and reporting obligations

USA - December 8 2014 On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial…

Amy K. Dow, Bonnie I. Odom, Robert E. Wanerman

FDA releases draft guidance updating agency policies on the informed consent process for clinical trials

USA - September 24 2014 On July 15, 2014, the U.S. Food and Drug Administration ("FDA") released draft guidance that provides extensive commentary on FDA's current thinking…

Amy K. Dow, Bonnie I. Odom

Contrary to misconceptions, a final guidance is not a final rule

USA - August 1 2014 Earlier this week, a popular source of regulatory news published an article claiming FDA "finalized a new rule this week that prohibits manufacturers…