Docket Management
Docket: 00N-1484 - Safety Reporting Requirements for Human Drug & Biological Products
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Dr. James Nickas Date/Time 2003-03-15 12:05:56
Organization Genentech, Inc.
Category Health Professional

Comments for FDA General
Questions
1. General Comments COMMENTS ON IND SAFETY REPORTS The Agency's proposed refinements to the IND safety report regulation (21 CFR 312.32) will help clarify many historical gray areas. Some additional clarifications would be helpful to industry. 21 CFR 312.32 states that the sponsor shall identify all safety reports previously filed with the IND concerning a similar adverse experience, and shall analyze the significance of the adverse experience in light of the previous, similar reports. QUESTIONS What is specifically meant by all safety reports previously filed with the IND? Does it mean all previously submitted IND safety reports to a singular IND or does the Agency interpret this to mean something broader? Industry has interepreted this regulation in many different ways. Should an analysis of similar events include previous similar reports across multiple open INDs or only a singular IND as the regulation implies? It should be recognized that there could be company-sponsored IND studies and investigator-sponsored IND studies going on simultaneously, with safety data stored in different places. What is practical to retrieve and include in a sponsor's IND safety report that is required to be submitted within 15 calendar days? What would be most useful to the Agency? Once an IND safety report is prepared, should it be sent only to Investigators participating in company-sponsored studies conducted under the singular IND, or to Investigators participating in company-sponsored and/or other studies conducted under all open INDs for the product? Should follow-up IND safety reports that contain minor refinements be sent to the FDA and all investigators who received the initial IND safety report or only to the FDA? Lastly, it would be helpful to the Agency to codify a requirement to submit all subsequent reports of a similar serious adverse drug reaction (i.e., possibly related) as an IND safety report until the applicable reference safety information document is officially updated (e.g., reprinted and distributed) to list and position the event in question as a possible adverse drug reaction. Some companies consider the reference safety information updated with submission of the first IND safety report. Thus, all subsequent reports of a similar event would be classified as expected for regulatory reporting purposes. This was not the intent of the original IND safety report regulation.




EC -4