Female chemist at work in laboratory.

Is the FDA Telling You Something?  Final Bioanalytical Guidance May Point the Way!

Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.”  This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized.  For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the draft guidance, it is now a good time to assess your procedures for compliance with the now-final guidance and revise them accordingly.

After quickly reviewing the guidance, one aspect that stands out is the frequency of the use of the word “sponsor” throughout.  Electronically searching for the word “sponsor” in the draft guidance from September 2013 and the previous guidance document from May 2001 reveals that “sponsor” appears five and two times, respectively.  However, the current final guidance invokes the word “sponsor” approximately sixty-five times.  It seems that the FDA is stressing the roles and responsibilities of the sponsors for the bioanalytical activities conducted by their bioanalytical testing partners more than it had in the past.  This is a friendly reminder to all clinical trial sponsors of their responsibilities to ensure the quality and integrity of study data.

Should you or your organization have any questions about implementation of the final guidance or need support for any aspect of your bioanalytical studies, please contact David O’Connor at d.oconnor@lachman.flywheelsites.com.