On October 23, 2014, FDA held a webinar to clarify the two draft guidance documents
that were released on October 3, 2014, regarding the proposed regulation of laboratory
developed tests ("LDTs"). FDA made several clarifying statements during the webinar,
both during the presentation and in the subsequent lengthy question and answer session.
The recorded webinar, transcript, and slides are posted on FDA's website. Katherine
Serrano from the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for
Devices and Radiological Health, walked participants through the timeline set out in the
draft guidance documents, explaining when certain requirements would be in effect.
read more
that were released on October 3, 2014, regarding the proposed regulation of laboratory
developed tests ("LDTs"). FDA made several clarifying statements during the webinar,
both during the presentation and in the subsequent lengthy question and answer session.
The recorded webinar, transcript, and slides are posted on FDA's website. Katherine
Serrano from the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for
Devices and Radiological Health, walked participants through the timeline set out in the
draft guidance documents, explaining when certain requirements would be in effect.
read more
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