On-line open house

Since Pharmaceutical Executive took readers on a tour of the FDA and EMEA World Wide Web home pages about a year ago, both agencies have turned over new leaves on the Internet. Come join us on a tour of FDA's virtual home in Washington, D.C., and EMEA's counterpart digs in London.

FDA

Although FDA's Internet architecture remains fundamentally the same, the agency has remodeled and updated some areas. Especially useful is a virtual door that leads to a text-only version of the home page for users who lack software to support graphics. Also, the brightly colored icons that open doors to FDA's many agency wings have been rearranged. Some of the icons, such as Human Drugs and Field Operations/Imports, now sport different graphics. One-Foreign Language-is a new door that leads users who speak English, Spanish, or Russian to selected categories of regulatory information. A tour of FDA's updated home page reveals the following developments:

The agency's home page now sports a "What's New" window. Here, browsers find links to timely information that FDA has made available on its Internet site during the past four weeks. From product recalls to finalized regulatory rules, users can tap into the latest agency activities.

Underlined text at the bottom of FDA's home page offers a link to the Department of Health and Human Services (HHS) "agencies" home page. Once inside, users can move to any HHS agency, from the Centers for Disease Control and Prevention to the National Institutes of Health.

A click on the updated Human Drugs icon links users to a wing with rearranged furnishings. This virtual room houses the Center for Drug Evaluation and Research (CDER), and new graphics now offer users entrees to many hallways. Here users can find information about the center's function, drug information, regulatory guidance, and current activities. Also new: the center's ombudsman, Jim Morrison, is now on line. Morrison's function is to provide an avenue for getting complaints that involve CDER programs resolved at a level close to the source of a problem. Users can communicate with Morrison by clicking on the Ombudsman underlined heading accessed through the "About CDER" link.

The new Foreign Language room, although potentially highly useful, may remain closed to many users. The special characters of the Spanish language may fail to display properly unless users tap into a graphic Web browser to read those documents. Also, to read the documents in Russian, users must have Cyrillic fonts installed in their Web browser. Once through the Foreign Language door, however, users can glean an overview of FDA's regulatory responsibilities, information about food additives and food-borne illnesses, imports and export procedures, and international trade organizations.

Biologics, which is home to the Center for Biologics Evaluation and Research (CBER), has greatly expanded its wing, adding many more categories of information. Whereas last year's review showed a brief page of text, this year's renovation provides virtual access to information on advisory committee meetings, CBER biological approvals, recalls and market withdrawals, and a wide variety of CBER files, including memoranda to blood establishments, CBER guidelines, letters to industry, and points-to-consider documents.

The Field Operations/Imports icon replaces the old Inspections and Imports door. Now expanded, today's revamped area that houses the Office of Regulatory Affairs offers information about science facilities, procedures, and techniques, and compliance and federal/state relations. The aim of the latter, according to the page, is to assist state and local officials to promote cohesive and uniform regulatory activities.

The "More Choices" door now offers users the opportunity to tap into information targeted to special audiences-health professionals, industry, media, and teens. The new interactive U.S. map on the industry page allows users to click on a region to access an FDA small-business representative. These strategically placed resource people can provide a variety of regulatory information and assistance. More Choices also lists contact information for Amanda Bryce Norton, FDA's chief mediator and ombudsman.

EMEA

The European Union (EU) Drug Regulatory Authorities Network, or EudraNet, has undergone extensive structural changes since PEs review of the site last January-including an entirely new foundation. The cooperative venture of EU's regulatory authorities houses the European Agency for the Evaluation of Medicinal Products (EMEA) Web site, now at a new address (see above). An added category, Pharm-Links, takes users to pharmaceutical industry-related information and sites. Graphics load more quickly, and EudraNet's new main index Web page simplifies navigation with its vertical columns of colorful click-on buttons that line the left side of the screen and link users to primary sites. Here are some highlights:

EMEA's new page now sports a "What's New from EMEA!" category. Inside, users can find the latest information about management board meetings, new guidelines from the Committee for Proprietary Medicinal Products (CPMP), and CPMP's European Pharmaceutical Assessment Reports, or EPARs, which provide the rationale for its opinions about new-product decisions.

EMEA's page also now offers its agency directory in both English and French. However, users must have specialized software to download the extensive file and view the voluminous text. Thus, that information seems less accessible than the simple text document that made up last year's page.

The new Pharm-Link page offers a mother lode of industry-related information. Here, users can tap into European and global sites of pharmaceutical-related industries, associations, and societies. Companies such as Ciba-Geigy, Merck, and Rhone-Poulenc have pages here, as do the National Institutes of Health and National Library of Medicine. A Yahoo! Directory of Pharmaceutical Companies is also available.

PharmInfoNet is yet another industry-related area within Pharm-Link. PharmInfoNet offers professional discussion groups, disease-center information, and news updates about pharmacotherapies. Users will find a multitude of virtual hallways to explore, including information about reporting adverse drug reactions to FDA.

EudraNet's Web address remains at http://www.eudra.org/. FDA's Web site is not part of EudraNet's Pharm-Link page, nor is EMEA's site part of FDA's cyberspace home. Connecting the two would offer users streamlined access to the world's two major regulatory agencies.