About WIS...

WIS 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 handling.

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 ExpertBriefings.com
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








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