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FDA Revised Inspection Guide April 18, 2011

Posted by Michael Hamrell in Regulatory Thoughts.
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The FDA has published an update to the Compliance Program Guidance Manual on the conduct of inspections of Sponsors/Monitors and CROs (CPGM 7348-810).  This is the first revision to this inspection manual since it was last updated in February 2010.  The basic inspection program has not changed, but there are several new considerations for the inspection.  The Manual instructs the Inspector to pay closer attention to the collection of investigator’s financial disclosure information, the company’s reporting of the study to clinicaltrials.gov, and the use of international data and the review of the study records.  There are also some revisions and updates to the oversight of the use of electronic records and electronic signatures.  As computerized systems become a bigger and bigger part of clinical trials, it is not surprising that this has received more attention.  Finally, the revised Guidance Manual gives the inspectors more detailed instructions on documenting violations, especially those that may involve fraud.

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Update to Informed Consent January 26, 2011

Posted by Michael Hamrell in Regulatory Thoughts.
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The FDA has published a final regulation to amend the informed consent regulations effective in March 2011. This rule will require that a statement be added to all informed consent forms to inform subjects that information regarding the study is available in a public registry database at clinicaltrials.gov .  Although the rule goes into effect in March 2011, it has an implementation date of March 2012 for all trials that are initiated on or after that date.  In addition, for any trial that has been initiated prior to that date, it will not be necessary to revise the informed consent form or reconsent subjects to comply with this new regulation.  In other words, it will not be applied retroactively.  Instead it only applies prospectively to new trials initiated on or after the implementation date.  Once the regulation is effective, even if a consent form is modified for other reasons and subjects are reconsented, compliance with this regulation will not be required.

The regulation goes into some detail to describe what FDA means by an study that has already been initiated. Basically, if the study has been approved by any IRB or other such committee it is considered initiated.  This also applies to multicenter trials.  If the trial has been initiated at any site, the whole study is considered initiated.  FDA acknowledges that as a result there will be a gap for some time period before all studies have this language, but they do not consider this to be a problem since the requirement for clinical trial registration has actually been in place since 2007 and many investigators verbally inform subjects of such access already or subjects have themselves figured it out.

PostMarketing Commitments November 26, 2010

Posted by Michael Hamrell in Regulatory Thoughts.
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More and more drug manufacturers are now required or agreeing to complete additional studies after approval of their drug product by the FDA. These postmarketing studies may be required as a condition of approval or agreed to by a sponsor to address additional issues, but not required by statute or regulation.

The FDA recently issued their 2nd Annual report on the status of the postmarketing studies for drug and biologic products. The FDA is required to report annually on the status of the postmarketing studies, as outlined in FDAAA from 2007. The report was completed by Booz Allen Hamilton for FDA. According to the report that covered over 1500 studies, 40 percent of the postmarketing studies/clinical trials had been closed (either fulfilled or released) by FDA. Of the remaining 60 percent, most were in progress and on schedule or the final report has been submitted for FDA review.

The information about postmarket requirements and commitments comes from Agency letters and from annual status reports submitted by applicants. According to the FDA, the information will be verified for accuracy before it is posted on the Web site, that is supposed to be completed ever quarter. Only 17% of the backlog of PMRs/PMCs were now considered delayed.