Tag: new submission process

CDER SBIA Webinar Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)

Nov. 1, 2019 1:00 p.m. Eastern FREE FDA is establishing a new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide sponsors with a […]

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