Other Key Sources Of Regulatory Intelligence

Databases

MediRegs. URL: http://www.mediregs.com. MediRegs, a Massachusetts-based publisher, offers two large, searchable document collections as separate subscription services.

The MediRegs Pharmaceutical Regulation Suite, available on CD/ROM, DVD, or the Web, focuses on U.S. publications. It includes the full text of public laws, pertinent Code of Federal Regulations and Federal Register material, citations to court cases back to 1938, and a huge compilation of FDA forms, manuals, guidelines, and other publications. Through a partnership with FOI Services, MediRegs offers access to sources also directly searchable on the FOI Online Web site described above. The Pharmaceutical Regulation Suite on the Internet is updated daily; CD/DVD versions are updated monthly.

MediRegs' European Pharmaceutical Regulation Suite assembles comparable documents generated by the EU, such as legislation, European Court of Justice Opinions, and EMEA guidelines and EPARs. This separately searchable collection is updated weekly on the Internet and monthly on CD/ROM.

IDRAC Regulatory Intelligence Database. Weekly. URL: http://www.idrac.com. Formerly produced by IMS, the IDRAC database system is a massive compilation of more than 34,000

regulatory documents related to all aspects of drug authorization, marketing, and production. The collection includes publications from more than 50 regulatory authorities worldwide. The IDRAC system is organized into country or regional modules available for separate subscription and includes explanatory documents written by expert consultants. IDRAC is accessible on a Web-based platform described in more detail at the URL cited here.

ESPICOM Country Health Care Reports. Chichester, Sussex, U.K.: ESPICOM Business Intelligence. Semimonthly. This database provides overviews of healthcare administration and provision, manufacturing and trade regulations, drug registration procedures, and price controls for any of 77 nations worldwide. Each country's report is divided into consistently labeled sections for separate searching and display. Portions of reports of primary interest to regulatory researchers are assembled under the general heading "Pharmaceutical Market Environment,'' where separate records address topics such as registration procedures and fees, exemption requirements for clinical testing of investigational products, labeling and packaging of imports, quality control, advertising, and patent protection.

Postmarketing Study Commitments (''Phase IV Database''). URL: http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm. "Phase IV" refers to clinical studies conducted after a drug is initially approved in the United States. Postmarketing studies are conducted for a variety of reasons. Their focus may be on collecting "real life'' pharmacoeconomic data that is difficult to obtain from the relatively limited trials conducted for registration purposes. Many post-approval studies are designed to gather more extensive information on a product's safety and efficacy during long-term administration. The FDA may also request pediatric trials for drugs previously tested only for use in adults. Companies sometimes initiate trials to verify a product's use for additional indications. The outcome of Phase IV studies often leads to supplemental NDA approvals for new therapeutic targets, new patient populations, or new formulations. The Web page cited here provides links to the FDA's annual performance report summarizing the status of postmarketing commitments and to a searchable database compiling information on individual studies. Each database record identifies the company name, product name, NDA/BLA number, date of approval, study status (e.g., pending or completed), and study objective. The search interface to the Phase TV Database enables retrieval of pertinent studies by one or more of the data elements included in records (except the narrative description of objectives). Thus, it's possible to examine all postmarketing commitments associated with a given company or product, further qualifying results only to pending studies, if desired. It should be noted that the Phase TV Database does not include commitments related to highly proprietary information, such as studies undertaken to evaluate chemical or manufacturing issues. Another source for early information about Phase IV agreements is NDA Approval Letters, accessible through the [email protected] database cited previously.

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