From:
`To:
`Cc:
`Subject:
`Date:
`
`Buckman, Paul
`O"Brien, Tim J. (CH)
`Mulieri, Chris
`FW: FDA Webmaster inquiry
`Wednesday, February 17, 2016 2:50:45 PM
`
`Mr. O’Brien –
`
`The PDF review package files were created by CDER/DIDP (FOI) on 2/20/2003. That information
`comes from the PDF metadata. Those documents were provided to my web team on or after that
`date. Since there is a backlog of items to be posted, as well as some processing time to create a
`linked review package, the documents were not uploaded until 3/7/2003. Both our administrative
`module and our file dates indicate that the files were posted on 3/7/2003. I have no records or
`reason to believe that the PDFs have been modified since our original posting date.
`
`Thanks for your inquiry,
`
`Paul Buckman
`Director, Division of Online Communications
`Center for Drug Evaluation and Research
`U.S. Food & Drug Administration
`
`
`
`From: Timothy.O'Brien@lw.com [mailto:Timothy.O'Brien@lw.com]
`Sent: Wednesday, February 17, 2016 2:18 PM
`To: Mulieri, Chris
`Subject: FDA Webmaster inquiry
`
`Hi,
`
` I
`
` am writing to inquire about the “Date created: March 07, 2003” tag on the following webpage:
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify.cfm
`
`We contacted a Drug Information Specialist who stated the following: “[T]he metadata on all PDF files
`in the review package are consistent, and haven’t changed since 2/20/2003. Our administrative
`module indicates that the review package was uploaded on 3/7/2003, which is consistent with the
`date found on the bottom of the webpage.”
`
` I
`
` would like to confirm this with someone directly involved in the web team, and I found your contact
`information online. Can I please have you confirm that the above statement is correct, that the
`webpage above has not changed since March 07, 2003, including that the “Approval Letter(s)” and
`“Printed Labeling” pdf’s have been accessible online in their current form since March 07, 2003? Or
`can you please redirect me to someone who might better be able to handle this type of inquiry?
`
`Thank you,
`
`Timothy J. O’Brien
`
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`
`Roxane Labs., Inc.
`Exhibit 1024
`Page 001
`
`

`
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`
`Latham & Watkins LLP
`
`Roxane Labs., Inc.
`Exhibit 1024
`Page 002