George C Phillips - Comment

Document ID: FDA-2010-D-0482-0002
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: November 18 2010, at 12:00 AM Eastern Standard Time
Date Posted: November 19 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: September 29 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: December 28 2010, at 11:59 PM Eastern Standard Time
Tracking Number: 80b98791
View Document:

This is comment on Notice

Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability

View Comment

With regards to BA/BE studies, page 19 of the draft guidance, part IX.C., second paragraph states that "For example, a report would be identified in box A5 of FDA Form 3500A as a Bioavailability/Bioequivalence Safety Report or a Followup Bioavailability/Bioequivalence Safety Report, as applicable." Shoud the be box "G5" and not "A5" which I believe is a typo. Also, will the MedWatch 3500A form be amended so that "BA/BE" is an option to check. Or should box G3, the "Other" box be checked with "BA/BE written in. Clarification would be appricated.

Related Comments

View All

Total: 23

George C Phillips - Comment
Public Submission Posted: 11/19/2010 ID: FDA-2010-D-0482-0002