Finalized ICH Guide Supports Global Approach To Collecting Genomic Samples, Data During Trials
A new guideline finalized by the International Council for Harmonisation is expected to facilitate global genomic studies by enabling a common understanding of critical underlying parameters.
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The International Conference on Harmonisation is working on establishing general principles on how sponsors can plan and design multi-regional clinical trials so as to facilitate the acceptance of data from such studies by multiple regulatory agencies1,2.
Following the US request for ranitidine drugs to be withdrawn from the market, the European Medicines Agency says it would decide the fate of the products in the EU after wrapping up its own inquiry.
Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.