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When must the sponsor submit an IND safety report to the FDA if an adverse event is serious and unexpected?

A sponsor of a clinical trial conducted under an IND must report serious and unexpected suspected adverse reactions to FDA in an IND safety report within 7 or 15 days depending on the severity of the event (21 CFR 312.32).

What are the 4 criteria for adverse event reporting?

There are only four requirements for a valid adverse drug reaction report: patient identifier, medicine, reaction, reporter details.

What are the FDA annual reporting requirements?

Specifically, this annual summary must include the name of the investigational drug, the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. FDA is required to specify the deadline for such reporting submissions.

What is the approval rate for breakthrough designation?

Since the FDA instituted its BT program in 2012, its Center for Drug Evaluation and Research has granted 83 approvals as of December 31, 2018. In 2020, the FDA granted 42% of the novel approvals breakthrough status.

How long does it take for breakthrough therapy designation to be reviewed?

What are the timelines for FDA to respond to a breakthrough therapy designation request? FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.

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What is the FDA system used to report adverse medication events?

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.

When must a sponsor submit an IND safety report to the FDA?

The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any investigators IND) in an IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than 15

When should an IND be submitted?

An IND can be submitted by the sponsor/investigator at any phase of the clinical trial stage but must be submitted prior to testing the experimental drug in human participants.

What are the FDA guidelines for reporting adverse events?

Submit an initial report with a new control number (Item 24b) on a Form FDA-1639 for a new, subsequent experience. Form FDA 1639 (and narrative increased frequency report if indicated) and submitting it to FDA. If it is a serious, unlabeled event, the Form FDA 1639 should be submitted within 15 days.

When should the sponsor notify the regulatory authority?

Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in writing) as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days.

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When must the sponsor submit an IND safety report to the FDA if an adverse event is serious and unexpected?

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What is the FDA system used to report adverse medication events?

When must a sponsor submit an IND safety report to the FDA?

When should an IND be submitted?

What are the FDA guidelines for reporting adverse events?

When should the sponsor notify the regulatory authority?

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