Regulatory Open Forum

Hi Kamana,

I also have not seen FDA define a format. I don't think the format matters as long as such a document is included in the submission. I have always used a two-column table format with the PI text on the left and the annotations on the right. That has been my practice for 30 years and FDA has never complained.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 31-Mar-2022 12:16
From: Kamana Singh
Subject: Annotated USPI

Hi,

I was wondering if there is a specific format preferred by FDA to submit annotated USPI.

I have seen a lot of variability in the ways annotated USPI is submitted across different companies, so wanted to understand what exactly is required by the FDA. I am not finding any specific guidance explaining this.

Any help is appreciated,

Thanks,

Kamana

Original Message:
Sent: 4/1/2022 8:13:00 AM
From: Glen Park
Subject: RE: Annotated USPI

Hi Kamana,

I also have not seen FDA define a format. I don't think the format matters as long as such a document is included in the submission. I have always used a two-column table format with the PI text on the left and the annotations on the right. That has been my practice for 30 years and FDA has never complained.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 31-Mar-2022 12:16
From: Kamana Singh
Subject: Annotated USPI

Hi,

I was wondering if there is a specific format preferred by FDA to submit annotated USPI.

I have seen a lot of variability in the ways annotated USPI is submitted across different companies, so wanted to understand what exactly is required by the FDA. I am not finding any specific guidance explaining this.

Any help is appreciated,

Thanks,

Kamana

This message was posted by a user wishing to remain anonymous

I much prefer the two column approach Glen mentions but it seems like there is a shift to using MS Word Comment bubbles; last half dozen new labels I've seen have taken this route.
Original Message:
Sent: 31-Mar-2022 12:16
From: Kamana Singh
Subject: Annotated USPI

Hi,

I was wondering if there is a specific format preferred by FDA to submit annotated USPI.

I have seen a lot of variability in the ways annotated USPI is submitted across different companies, so wanted to understand what exactly is required by the FDA. I am not finding any specific guidance explaining this.

Any help is appreciated,

Thanks,

Kamana

Dear Kamana,

Submission of the proposed text of the label as a clean copy and as a marked up or track changes versions facilitates timely review and discussion of counter proposed or edited language.  In my personal experience,  annotated USPI submitted in MS-word with track changes "all markup" and "show revisions in balloons" (on the right side) enabled helps the review team identify each proposed change and provide a way to "reply" and communicate the Agency's agreement/s or request/s for additional content and format edits as needed, but this is not a requirement.  You may want to perform a quality check before filing your annotated USPI using the "Selected Requirements of Prescribing Information (SRPI)" checklist available at https://www.fda.gov/media/87094/download

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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not necessarily represent the postings, strategies, opinions, legal advice of the U.S. Food and Drug Administration**
------------------------------

Original Message:
Sent: 31-Mar-2022 12:16
From: Kamana Singh
Subject: Annotated USPI

Hi,

I was wondering if there is a specific format preferred by FDA to submit annotated USPI.

I have seen a lot of variability in the ways annotated USPI is submitted across different companies, so wanted to understand what exactly is required by the FDA. I am not finding any specific guidance explaining this.

Any help is appreciated,

Thanks,

Kamana