New ICH Q&A To Support Uptake Of 'Vague' Safety Guideline For Anticancer Drugs
All parties that have used the ICH S9 guideline on the non-clinical evaluation of anticancer medicines have
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The International Council on Harmonisation has endorsed draft versions of two new guidelines – one on conducting multi-regional clinical trials and the other on supporting the non-clinical evaluation of anticancer medicines. The ICH is now seeking stakeholder feedback on both documents.
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.