Docket Management
Docket: 00N-1484 - Safety Reporting Requirements for Human Drug & Biological Products
Comment Number: EC -10

Accepted - Volume 3

Comment Record
Commentor Dr. James Sanders Date/Time 2003-04-10 17:33:50
Organization Aventiss Pharmaceueticals
Category Company

Comments for FDA General
1. General Comments Under IND Safety Reports, II.B.2.c, the proposed sentence change to &312.32(c)(1)(ii) contains the phrase ... might materially influence the benefit risk assessment... which requires clarification. Literal interpretation would require a safety report for changes which are favorable to the benefit risk assessment, nonclinical finding which would reduce the NOAEL eventhough an adequate margin of safety would still exist and it would have no influence on the clinical use of the drug, or clinical studies would indicate a higher clinical dose would be required for efficacy even though this higher dose is well supported by clinical and nonclinical safety data.

EC -10