Global Pharma Guidance Tracker – Sept-Oct 2016
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Sponsors of new and existing medicines in New Zealand will have to update their product labels within specified deadlines to include warning statements about certain allergens.
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.