Ways and Means: Your FDA Electronic Access Guide

From The PDA Letter - the monthly newsletter of PDA.

Revised August 1995.

For further information: contact Virginia Ventura (ventura@pda.org, Tel. +301-986-0293, Fax +301-986-0296).


In an effort to serve our members better, we have assembled the most complete reference available of ways to access FDA drug, medical device and biologic public information electronically, including automated telephone and fax systems.The following information was drawn from sources provided to us by FDA. In many cases, phone numbers of contact people are listed in case you run into trouble. FDA is rapidly increasing and improving its high technology communications, and the following information is subject to change without notice at any time.

TELEPHONE

CBER Audio Information System, 301-594-1800

Information available: instructions for making FOIA requests and obtaining certificates to foreign governments. Allows callers ability to speak with consumer safety officers and to leave messages.

FDA Committee Management Audio Telephone System, 800-741-8138

Information available: advisory committee meeting schedules and related information for CBER, CDRH, CDER, Center for Food Safety and Applied Nutrition, CVM, NCTR and the Office of the Commissioner.

FAX-BACK SERVICES

CDRH Fax-on-demand System, 301-827-0111, 800-899-0381

Documents available: large selection from Division of Clinical Laboratory Devices; Division of Cardiovascular, Respiratory and Neurological Devices; Division of General and Restorative Devices; Division of Ophthalmic Devices; Division of Reproductive, Abdominal, ENT and Radiology Devices; and others.

CBER Fax Information System, 301-594-1939

Documents available: a lengthy list of documents, including Federal Register notices, Points to Consider, Memoranda to Industry, and a CBER mail directory. CDER documents are also available from this system. Foreign callers must call from a handset on a fax machine.

CDER Fax on Demand System, 301-827-0577

This is a new service that went on-line July 20, 1995. Documents available: New Drug Application guidelines; Office of Generic Drugs Policy and Procedure Guides; Points to Consider documents; Approved Drug Products (the Orange Book) ordering information; Talk Paper articles; and miscellaneous guidelines. Questions, call 301-594-1012.

DIAL-UP BULLETIN BOARD SERVICES

FDA Division of Field Investigations BBS, 301-443-2893

Documents available for download: various inspection guides intended to serve as reference materials for FDA investigators and other FDA personnel. These guides are not intended to serve as a medium for establishing new procedures, standards or requirements. Use zmodem transfer protocol. If you experience problems, contact Division of Field Investigations, 301-443-3340.

FDA Public Affairs BBS, 301-594-6849 (login "bbs")

Documents available: Federal Register summaries; list of upcoming FDA meetings; access to CDRH electronic docket; news releases; enforcement reports; drug and device approvals list; AIDS information; FDA testimony at Congressional hearings; speeches. No ability to download files, but you can always capture to your hard disk. Must use specific commands; type 'help' for a list.

CDRH Electronic Docket BBS, 1-800-252-1366 or 301-594-2741

Documents available: medical device policy statements and operating procedure guides. The agency has decided to immediately cease maintenance of a'hard copy' docket for the same documents. Use KERMIT transfer protocol. For additional information, contact John Stigi, 301-443-6597.

INTERNET

FDA World Wide Web (WWW) Home Page: http://www.fda.gov

Many resources available, including: biotechnology; consumer advice; cosmetics; food additives, food labeling; pesticides and chemical contaminants; NCTR gopher site, CFSAN FTP site. Entire FDA phone book available in zip format, access to FDA Public Affairs BBS, other regulatory agencies including DFST in Australia and the International Food Information Council Foundation. Web searching available. Links to other useful places, such as the DHHS WWW Server, which contains a huge index of information available by topic and links to other federal government sources.

NCTR Gopher: gopher.nctr.fda.gov

National Center for Toxicological Research (NCTR) - lots of links to other organizations.

CDER Gopher: gopher.cder.fda.gov

You will see a menu structure of available files,their formats and sizes. Many files are available in ASCII, WP 6.0 and WP 5.1 format. Get the readme file (in ASCII) for a complete listing of documents. Some documents available: approved drug products list; transcripts of key meetings; CANDA directory; text of proposed rule on electronic signatures; Human Drug CGMP notes; directory of CDER fax numbers; FDA phone directory; SAS drug stability analysis program; and more. Some CBER documents are also available in the CBER directory. Questions, call Paul Motise at 301-594- 1089, e-mail at motise@fdacd.bitnet. A WWW home page is in the works.

CDER FTP Server: ftp cdvs2.cder.fda.gov

Files as above. Supports anonymous logins. Use any password, and binary transfer protocol.

CBER Internet E-Mail Address: cber_info@a1.cber.fda.gov

Use to make CBER document requests. A list of documents available by return e-mail can be requested by sending a message to do_list@a1.cber.fda.gov. Any mail system that can send and receive mail, including MCI Mail, Prodigy, CompuServe and America Online, as well as private systems with Internet connections can use this service. Comments or suggestions can be sent to Mark Elengold at elengold@a1.cber.fda.gov.

Many FDA employees can be reached by e-mail. Ask them individually for addresses.


The PDA Letter is published monthly by PDA, 7500 Old Georgetown Rd., Bethesda, MD 20814 USA. PDA membership dues includes a subscription. Fax +301-986-0296 or e-mail fry@pda.org for membership information.


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