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Pharmaceuticals / Regulatory Affairs

FDA Spells Out New Requirements for Submitting Electronic Safety Reports for INDs

Nov. 8, 2019
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The FDA outlined new electronic submission requirements for sponsors of investigational new drug applications (INDs) that apply to certain IND safety reports in a draft guidance.

Under current regulations, IND sponsors must submit IND safety reports to the agency via a standardized form in either paper or PDF format — an “inefficient and labor intensive” process, said CDER Director Janet Woodcock.

Submission of the information “as electronic data in structured data elements will improve the FDA’s ability to review and track the safety signals that occur during the conduct of clinical trials,” she said.

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