*************************************************************** ****************** WELCOME TO SGML NEWSWIRE ******************* *************************************************************** * * * To subscribe, send mail to sgmlinfo@avalanche.com * * * * (Please pass along to interested colleagues) * * * *************************************************************** FDA STARTS TO GET SERIOUS ========================= The following e-mail message, distributed simultaneously to several LISTS, was contributed by an SGML Newswire subscriber. Date: Mon, 13 Sep 1993 Reply-To: "Publishing E-Journals : Publishing, Archiving, and Access" From: Norman Schmuff 443-9620 Subject: FDA Electronic Submissions (CANDA) To: Multiple recipients of list VPIEJ-L Many options are currently being explored for electronic regulatory submission at the US Food and Drug Administration. These electronic documents are generally referred to as CANDAs (Computer Assisted New Drug Applications). One small project is underway, in conjunction with a few pharmaceutical firms, to prototype an electronic regulatory submission, based on non-proprietary file interchange formats. File formats will include SGML for text, and CGM for vectorized graphics. Other chemistry specific file formats being considered are: for chemical structure/reactions SMD, and MDL's MOLFILE; and for analytical instrument data netCDF and JCAMP. This project is largely modeled on those standards promoted by the Department of Defense in the CALS initiative. The project is currently restricted to a portion of the "Chemistry, Manufacturing and Controls" (CMC) section. The first public showing will be 13 and 14 October in Philadelphia at a meeting sponsored by the Graphics Communication Association (GCA). For more information contact: Graphics Communication Association 100 Daingerfield Rd Alexandria, VA 22314-2867 703-519-8160 703-548-8160 (FAX) Comments or suggestions on this specific project should be sent personally to me: schmuffn @ fdacd.bitnet Norman R. Schmuff, Ph.D. FDA, HFD-530 ************************************************************** * SGML NEWSWIRE LIST MANAGER * * * * Linda Turner * * Corporate Communications * * Avalanche * * 947 Walnut Street * * Boulder, CO 80302 * * sgmlinfo@avalanche.com * * linda@avalanche.com * * Vox: (303) 449-5032 * * Fax: (303) 449-3246 * **************************************************************