US FDA extends comment period for post-marketing safety reporting rule
This article was originally published in RAJ Devices
The US Food and Drug Administration is providing more time for stakeholders to respond to its proposal to establish post-marketing safety reporting requirements specific to combination products1,2.
You may also be interested in...
In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.
EU regulators have agreed on supplementary pharmacovigilance requirements applicable to COVID-19 vaccines following approval.