Web Sites

FOI Services. URL: http://www.foiservices.com. (accessed October 2005). Founded in 1975 to facilitate the flow of information under the Freedom of Information Act (FOIA), FOI maintains a private library of over 150,000 FDA documents in all categories of products regulated by the agency. If FOI has the document requested, it can be downloaded immediately. FOI can request documents not in its own files from the FDA. The request is made in its name, protecting the identity of the actual requestor. The time required to obtain a document from FDA varies dramatically depending on the type of information sought. FOI Services also produces the DIOGENES® FDA Regulatory Updates online database. DIOGENES provides access to unpublished FDA documents online, both citations and full text. Containing over a million records, full text documents include Advisory Committee Minutes, FDA Guidelines, Warning Letters, Drug Summary Bases of Approval, Device Summaries of Safety and Effectiveness, Medical Device Report (MDR) Summaries, and Approved Product Listings for Device 510(k)s and PMAs. The database contains the full text of the newsletters published by Washington Business Information, including Devices & Diagnostics Letter, Europe Drug & Device Report and The GMP Letter. The full-text of several FDA publications are available, such as FDA Drug & Device Product Approvals, FDA Enforcement Report, FDA Federal Register Notice Summaries, and Talk Papers. Diogenes is available through the Dialog®, DataStar™, and STN database vendors.

MediRegs. URL: http://www.mediregs.com (accessed October 2005). Provides regulatory and compliance databases to medical device, pharmaceutical, and food industries. For the device industry, provides two "libraries" of services: MediRegs + FOI

Device Library, and European Device Regulation Library. MediRegs + FOI Device Library includes all of the regulatory information from MediRegs' Device Regulation Library, together with FOI Services collections of full-text Warning Letters, Inspection Reports, 483s, 510Ks, PMAs, Medical Device Reports, and more. MediReg files include FDA and NIH manuals, Code of Federal Regulations, U.S. Code and public laws, and court cases back to 1938. The European Device Regulation Library includes documents covering medical device vigilance systems, CE marking, device classification, European Court of Justice opinions, European Commission MedDev Guidelines, and more. Alert features allows user to create a personal "watch list'' of topics or terms. Subscription required for access.

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