FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector.
With the CLIA Waiver guidance appearing to be so prescriptive, why has denial dominated the review outcome?
By attending this this two-day workshop conference on Clinical Laboratory Improvement Amendments (CLIA) attendees will:
Note: Use coupon code 232082 and get 10% off on registration.
For Registration - http://www.complianceonline.com/how-to-get-a-clia-waiver-for-medical-device-seminar-training-80217SEM-prdsm?channel=pickevent
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