Hi David,
I agree with your comments. I am primary liaison to carry out Annual Report for IND/NDA/BLA submissions. While processing ARs in daily basis, I do submit an entire IND Annual Report even though there is no clinical pharma or clinical trial conducting. I simply indicate there is no update took place in reporting period in all 9 sections. On the other hand, every new IND we are filing, we are requesting FDA to give waiver of submitting DSUR instead whole Annual Report.
Tom, I do want to ask you questions. Is it possible to convert DSUR for legacy products? These are products which have been approved in early 90s and 2000.
Thanks,
------------------------------
Prakash Patel
Sr. Regulatory Submission Management
Roche (TCS)
Midland MI
United States
Original Message:
Sent: 03-16-2016 12:20
From: David Lim
Subject: DSUR question
Tom,
I provide extensive training services to the global audience.
"My question: if there was no activity during the reporting period......Or do we need to submit a complete DSUR? The FDA Guidance on DSURs does not speak to this."
In response to your question above, in both the US and EU, the DSURs, submitted annually, can take the place of the IND annual report and EU annual safety report. Yes, a complete DSUR (all sections) should be submitted but please state "no info is available" under the relevant sections.
When doing so, you can also indicate your coming year plan (e.g., keeping them active) under the section "region specific info."
Thank you.
s/ David
______________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Phone (Toll-Free): 1-(800) 321-8567
"Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
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