Drugs

Electronic Format for IND Safety Reports

FDA has issued a draft guidance, Providing Regulatory Submissions in Electronic Format: IND Safety Reports, describing the electronic format sponsors will be required to use when they electronically submit to FDA IND safety reports for serious and unexpected adverse reactions. The document implements the electronic submission requirements of Section 745A(a) of the Federal Food, Drug, and Cosmetic Act and applies to specified IND safety reports that are submitted to CDER or CBER. It changes the electronic submission requirements for this category of IND safety reports by requiring sponsors to submit the reports to the FDA Adverse Event Reporting System (FAERS) in accordance with the guidance.

The requirement will be effective 24 months after publication of the final guidance on the topic, FDA says. Before the effective date, the agency will accept IND safety reports to FAERS as part of a voluntary submission program.

FDA also released a final guidance, Electronic Submission of IND Safety Reports Technical Conformance Guide, with specifications, recommendations, and general considerations on how to submit electronic IND safety reports to CDER or CBER. The guide supplements the draft guidance issued at the same time.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome