US FDA asks industry for better info to facilitate import clearance
This article was originally published in Clinica
The US Food and Drug Administration has issued a letter outlining the kind of information that importers of medical devices should provide to allow the agency to make prompt admissibility decisions about their products arriving at designated ports of entry.
You may also be interested in...
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.