by chuck_ltd | 8 Jul, 2017 | EHR, eletronic Signatures, GCP, News
The FDA released a new draft guidance document on 21 June 2017. Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. >>>Link to Draft Guidance Document: Use of...
by chuck_ltd | 9 May, 2016 | CHCUK News & Articles, News, NIS, PROs
The importance of the patient’s point of view on their health status is fully acknowledged and such information may be used in drawing regulatory conclusions regarding treatment effects, in the benefit risk balance assessment or as specific therapeutic claims in...
