Tag: IND Safety Reports

FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

The FDA just issued draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports and associated technical specifications documents. The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research intends to implement a digital framework for the electronic submission, review, and tracking of certain investigational new drug (IND) safety […]

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