Newsletter - April 15, 2021
FDA’s Guidance for Remote Audits: Good Intentions, Bad Perceptions
Yesterday, 14 April 2021, FDA released a new Guidance Document on remote audits, which could have been more appropriate in April of last year than now. While the GAO and other independent groups have been panning FDA for not conducting on-site audits, this guidance seems to push back hard by proposing...Read More
Its Time To Restart Clinical Trials in the US
With wider vaccination and easing of mobility restrictions in the US, this is the time to restart clinical trials suspended or postponed last year due to the pandemic. But it may not be as simple; there are five areas of consideration for clinical trial restart. First, availability of human resources is still not at the pre-pandemic levels at most clinical trial sites. Read More
FDA’s Guidance for Remote Audits: Good Intentions, Bad Perceptions
Yesterday, 14 April 2021, FDA released a new Guidance Document on remote audits, which could have been more appropriate in April of last year than now. While the GAO and other independent groups have been panning FDA for not conducting on-site audits, this guidance seems to push back hard by proposing...Read More
Its Time To Restart Clinical Trials in the US
With wider vaccination and easing of mobility restrictions in the US, this is the time to restart clinical trials suspended or postponed last year due to the pandemic. But it may not be as simple; there are five areas of consideration for clinical trial restart. First, availability of human resources is still not at the pre-pandemic levels at most clinical trial sites. Read More
