Introduction

Government regulations exert a profound influence on the pharmaceutical industry. Virtually every aspect of drug development and marketing is affected by government oversight, which is initiated to protect citizen consumers. Ensuring the safety, efficacy, and quality of medicines is the primary focus of national drug regulatory policies. Stringent review procedures govern each step toward obtaining marketing authorization and require extensive product testing before commercialization. Another set of rules center on postmarketing safety surveillance, resulting in programs for systematic monitoring of adverse effects and enforcement mechanisms to correct product problems. A third category of regulations

addresses quality control issues in medical product manufacturing and testing facilities.

The organization of information sources discussed in this chapter follows this three-part approach to classifying government oversight activities in the pharmaceutical industry. Predictably, some publications defy attempts to arrange materials into applications-oriented categories. For example, databases that compile huge collections of regulatory documents typically provide information to support many different areas of investigation. Large Web sites maintained by government agencies also challenge the bibliographer intent on presenting sources in lists to match specific information needs. Further examination often reveals that such sites contain discrete databases, which, if identified in separate entries, are more readily recognizable as subject specialty sources designed to answer targeted categories of questions. Accordingly, the bibliography that follows cites multiple Internet addresses (URLs) that begin with the same "home page'' indicators, but continue with more precise pointers to unique databases located within the Web site. Massive and often difficult-to-navigate collections housed (or hidden) under one general Internet address require this "divide and conquer'' approach to make any description of their content useful.

Another issue in organizing a bibliography for practical use is identification of publication format. Traditionally, discussion of the literature singles out abstracts and indexes, online databases, books, and periodicals as separate categories. Recent developments have added another format to the list: Web sites. As mentioned previously, the distinction between Web sites and online databases is somewhat blurred. Today, most online databases are available on the Internet. However, their descriptions in this chapter will omit a URL when they are marketed by more than one vendor or accessible through multiple search "platforms." It's safe to assume, nonetheless, that any database cited here is on the Web, and a keyword query using its title, when submitted through a general search engine such as Googleâ„¢, will lead to pertinent URLs.

Regulatory research requires rapid access to full-text, up-to-date documents. Therefore, information professionals in this discipline rarely use hardcopy ("printed") abstracts and indexes. Online databases and web sites are, by far, the predominant source of answers to regulatory questions. Newsletters are also an important category of resources in this subject specialty. Here too, electronic formats are preferred. Publication in this form enables more timely updating and dissemination and provides keyword search capabilities. Thus, many titles identified as newsletters could also be classified as databases.

What about books? The lists included below are quite selective. Many books marketed to regulatory affairs personnel merely carve out a subset of government documents and repackage them in handbook format. Although convenient for their portability and attractive for their selectivity in subject emphasis, books of this type will not be found in this bibliography. The same material is readily accessible online, where it is much more rapidly updated and more easily searched, due to retrieval capabilities well beyond back-of-book index terms. Those few books that have been cited here are texts containing background information on the regulatory process that is very difficult to find elsewhere.

Effective use of the literature requires some familiarity with the subject matter addressed, its vocabulary, and the implications and applications of documents likely to be the topic of inquiries. Introductions to each section of the bibliography, as well as annotations for specific resources, include explanatory information intended to assist readers in assessing the significance of individual resources described. Although no more than brief overviews, these introductory notes may help in defining terms and identifying abbreviations and acronyms that crop up in inquiries related to regulatory affairs. In addition, annotations for individual sources sometimes point to significant differences in search capabilities.

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