Co. publishes Warning Letter Bulletin, a monthly newsletter that summarizes
all Food and Drug Administration (FDA) "warning letters" and
“untitled letters” to manufacturers of drugs, devices, animal
drugs, foods, dietary supplements and blood products; Food & Drug
Inspection Monitor, a monthly newsletter that analyzes FDA inspections
of drug and device manufacturers and blood banks; Validation Times, a
combination monthly print newsletter with electronic E-mail updates on
drugs and biologics regulation, focusing on process, cleaning and computer
validation; and BioResearch Compliance Report, which monitors clinical
research inspections by FDA and the Office of Human Research Protections
of the Department of Health and Human Services. BiMo also is a combination
monthly print newsletter with Email updates; Adverse Event Reporting News,
a biweekly publication delivered in PDF format, which monitors FDA and
EU regulation of adverse event reporting, pharmacovigilance and complaint
All subscribers can use WIS' RECORD-RETRIEVE Document Retrieval &
Research Service which provides documents from FDA or any other government
agency for a fee.
All WIS newsletters are available on-line through CompuServe, Dow Jones
News Retrieval, Dialog and other fee-access on-line data bases provided
through The Gale Group.
WIS also publishes the following books and electronic products: 510(k)s/PMAs
on DVD, Drug & Device Answer Book, Electronic Signature/Records Manual,
FDA Computer/Software Manual, QS/Design Controls Guide, FDA Guide to Systems-Based
Inspections, 483s and EIRs on CD, BioResearch Monitoring Handbook, and
Guide to Vigilance and Adverse Event Reporting WIS documents are listed
on the World-Wide Web, WWW.FDAINFO.COM.
WIS also airs audioconferences on specialized topics through its subsidiary
WIS also provides information to the news media and consumers on an as-needed
basis through its Editor & Publisher, Kenneth Reid, who has more than
20 years experience in journalism and 15 years covering the FDA and other
U.S. regulatory agencies. Reid also has written for several trade newsletters
and magazines on topics related to health care and food and drug regulation.
He has covered issues related to every product that FDA regulates.
WIS is an independent newsletter publisher and is not part of any trade
association, lobbying group nor government agency. It is incorporated
in the state of Maryland, with offices at 208 South King Street, Suite
303, Leesburg, VA 20175