Docket Management
Docket: 00N-1484 - Safety Reporting Requirements for Human Drug & Biological Products
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Dr. James Nickas Date/Time 2003-03-17 13:50:17
Organization Genentech, Inc.
Category Health Professional

Comments for FDA General
1. General Comments COMMENTS ON MINIMUM DATA SET AND FULL DATA SET FOR AN INDIVIDUAL CASE SAFETY REPORT The Agency is proposing that manufacturers submit a full data set for post-marketing individual case safety reports for serious SADRs, always expedited reports, and medication error reports. A full data set is defined as completion of all applicable elements on the FDA Form 3500A, VAERS form, or CIOMS I form. Without a little more specific guidance, this could be interpreted to mean that submission of some data in all fields of the aforementioned forms would constitute a full data set as currently defined. To help ensure that the Agency receives higher quality narrative summaries, the Agency should reinforce in regulations and/or guidelines what constitutes a complete enough narrative summary for most individual case safety reports. For example, the current instructions for completion of FDA Form 3500A indicate describe the event in detail using the reporter's own words, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.).... It should be noted that in the proposed rule, the Agency defines outcome as serious or non-serious. However, clinical outcomes of a reported event are usually described in terms like resolved, not resolved, resolved with sequelae, fatal, etc. The Agency should clarify if manufacturers are expected to pursue clinical outcome information during follow-up or outcome as defined by the Agency (i.e., serious or non-serious). For post-marketing individual case safety reports of serious ADRs, always expedited reports, and medication error reports, industry would like to know when active querying can stop. In other words, when is the case report complete enough for standard evaluation?

EC -6