Date:         Thu, 20 Apr 2000 13:23:03 +0200
Reply-To:     Lex Jansen <f.jansen@ORGANON.OSS.AKZONOBEL.NL>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Lex Jansen <f.jansen@ORGANON.OSS.AKZONOBEL.NL>
Organization: SURFnet BV
Subject:      Re: 12 pt font size and the FDA

The FDA also writes in their Guidance for Industry (IT 3, page 4):

"This guidance has been prepared by the Center for Drug Evaluation and
Research (CDER) in
cooperation with the Center for Biologics Evaluation and Research (CBER) at
the Food and Drug
Administration. This guidance document represents CDER’s current thinking on
regulatory submissions in
electronic format. It does not create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the
applicable statute, regulations, or both."

Especially the last sentence is interesting.

When they talk about Times New Roman and 12-point font, they specifically
talk about narrative text.
So this seems to support what Randy is saying.

Lex Jansen
NV Organon


Roland wrote in message <38FB877B.62A7@virgin.net>...
>Randy Childs wrote:
>>
>> Is this truly a REQUIREMENT or is it a PREFERENCE?  I have worked on
projects
>> in which we are creating tables and listings (that will go to the FDA) in
an 8
>> pt font.  In fact, on one of the projects the client told the FDA that it
may
>> be necessary to use a font as small as 7 points and the FDA was willing
to
>> accept this.  I would check the regulations.  A 12 point font may be
necessary
>> for the study report, but it may not be a "requirement" for the
supporting
>> tables and listings.
>>
>> Randy Childs
>> Senior Stat Programmer
>> Boston Biostatistics, Inc.
>
>Check out the FDA guidelines, especially where they say they might
>REFUSE an electronic submission if it is illegible. In other words their
>operatives with their standard computer screens cannot read it properly
>because the writing is too small to read. You need to work out if your
>"supporting" tables and listings are exempt. I can't see anything
>covering that.
>
>It's all on their website.
>
>Roland