Medical Writer's Resource Summary

[Laura Bean Warner <laura -dot- bean -at- DELTEC -dot- COM>]

Thank you to those of you who answered my request for internet addresses
and/or books relating FDA and EU requirements for documentation.

Here's a list of the sources I had and those I received from list members.

http://www.FDA.gov/
http://www.medicaldesignonline.com/
http://news.medicaldesignonline.com/regulatory-news/
http://www.eurunion.org/infores/resguide.htm
http://www.hc-sc.gc.ca/hpb/drugs/
http://www.europa.com/
http://www.raskaskygroup.com/
http://www.fda.gov/cdrh/

U.S. Department of Health and Human Services. Food and Drug Administration.
Center for Devices and Radiological Health. Medical Device Labeling--
Suggested Format and Content.  April 25, 1997.

--. Labeling Regulatory Requirements for Medical Devices. August1989.



Publishing Your Medical Research Paper by Daniel W. Byrne
"It contains a list of more than 400 Internet addresses for medical writers.
The scope is writing research articles but you may find the Internets
helpful for FDA and EU requirements."

Medical Writing in Drug Development by Robert J. Bonk, PhD --
The Pharmaceutical Products Press (an imprint of Haworth Press), $19.95.

Both of the above books available from The Haworth Press!

                 http://www.haworthpressinc.com
               e-mail: getinfo -at- haworthpressinc -dot- com

DeSain, Carol. Documentation Basics: That Support Good Manufacturing
Practices.  Paperback (January 1993) Aster Pub Corp; ISBN: 0943330416

--. Documentation practices : a complete guide to document development and
management for GMP and ISO 9000 compliant. Advanstar Communications, Inc.;
ISBN: 0929870395      $124.95, Hardcover - 180 pages


Thanks,
Laura Bean Warner
(laura -dot- bean -at- deltec -dot- com)

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