FDA and EMA push ahead with joint efforts to kick-start pediatric cancer drug development plans
As part of an effort to ease the processes around pediatric cancer drug development, the FDA and European Medicines Agency on Wednesday unveiled a new template to provide companies with an easier way to seek scientific advice from both agencies.
The FDA and EMA have more closely aligned their timelines for the required submissions of plans for pediatric development of new cancer drugs, which has opened up an opportunity for sponsors to seek preliminary scientific advice from both regulators simultaneously.
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