Newsletters and Journals

Health News Daily. 1989- . Chevy Chase, MD: F-D-C Reports. Daily. Published in both hardcopy and online format, this newsletter highlights Congressional and FDA activities in executive briefing style. It is designed for current awareness and focuses on legislative, regulatory, and (more selectively) business developments in the U.S. Health News Daily could be regarded as a precursor to more detailed coverage of industry-related events provided in other newsletters from the same publisher (see F-D-C Reports database).

The Pink Sheet: Prescription Pharmaceuticals and Biotechnology. 1939- . Chevy Chase, MD: F-D-C Reports. Weekly. Not limited to regulatory affairs alone, this newsletter is also highly respected for its thorough reporting of significant R&D advances and business developments affecting the drug industry in the United States. In addition to brief news items, each issue includes lengthier articles that provide useful background and commentary on significant events, such as Congressional hearings or FDA Advisory Committee meetings. The Pink Sheet is available by subscription in hardcopy format and through a Web-based platform for searching. The F-D-C Reports database online also offers fully searchable complete text of current and back issues.

F-D-C Reports. 1987- . Chevy Chase, MD: F-D-C Reports. Weekly. Full-text newsletters included in this database provide timely reports and commentary on U.S. legislative and regulatory developments, as well as business events likely to affect the pharmaceutical industry. For example, separate records for every U.S. drug or device recall or court action since 1988 are accessible in The Pink Sheet (prescription products), The Tan Sheet (OTC or nonprescription products), and The Gray Sheet (medical devices and diagnostics). The Pink Sheet is also a source for lists of new ANDA approvals and tentative approvals, posted at least twice a month. Other publications available in the F-D-C Reports database are The Gold Sheet: Quality Control Reports and Pharmaceutical Approvals Monthly (both annotated separately above). The combined F-D-C newsletter collection also includes: The Silver Sheet (medical device quality control), The Rose Sheet (cosmetics, toiletries, and personal care products), The Blue Sheet (health policy and biomedical research), and The Green Sheet (weekly pharmacy news).

U.S. Regulatory Reporter. 1992- . Waltham, MA: PAREXEL International. Monthly. The U.S. Regulatory Reporter focuses on FDA-related activities. It provides executive summaries of significant enforcement actions, proposed and final regulations, speeches by Agency officials, and Advisory Committee meetings. It also highlights new product approvals. Each hardcopy newsletter issue includes a separate section entitled "Biologics and Biotech Regulatory Report.''

EURALex. Richmond, Surrey, U.K.: PJB Publications, 1991-. Monthly. EURALex (formerly ERA News) reports on legal and regulatory affairs likely to affect the human and animal drug and device markets worldwide. Coverage includes changes in the structure and organization of national healthcare systems and individual national governments' policies regarding pricing and reimbursement. In-depth articles often provide expert commentary on significant legislation, court actions, and changes in patent or trademark law. This publication is available by subscription in hardcopy format and in electronic format distributed through the publisher's Web site. The Pharmaceutical and Healthcare Industry News Database (PHIND) also provides full-text search capabilities for accessing

EURALex and ERA News back to 1994, as well as pre-publication access to forthcoming articles.

Scrip: World Pharmaceutical News. Richmond, Surrey, U.K.: PJB Publications. Two issues per week (in hardcopy). Daily (online). Scrip is required reading for pharmaceutical executives and other industry watchers. Its international scope encompasses a broad spectrum of scientific, political, regulatory, and business news. Reports of events include informed commentary, critical evaluation of their potential significance, and trend analysis. PJB supplies this publication in both hardcopy and electronic format. Accessible to subscribers through the publisher's own Web-based platform, Scrip is also available for full-text searching in the PHIND database (see below).

Pharmaceutical and Healthcare Industry News Database. 1980- . Richmond, Surrey, U.K.: PJB Publications. Daily. PHIND includes the full text of several subject specialty industry newsletters also issued in hardcopy format, including Scrip (see above), Clinica (its counterpart for the medical device and diagnostics industries), Animal Pharm (animal health and nutrition), BioVenture View (business developments in biotechnology), Instrumenta (analytical and laboratory instruments), and Target (drug delivery industry). PHIND also provides full-text access to EURALex (1994 forward), cited previously in this section.

The Regulatory Affairs Journal—Pharma (RAJ Pharma). 1990- . Richmond, Surrey, U.K.: PJB Publications. Monthly. RAJ Pharma specializes in providing regulatory intelligence, news, and opinion for the pharmaceutical industry worldwide, covering developments related to both human and veterinary drugs. This journal, international in scope, reports on pertinent legislation, application requirements and guidelines, pharmacovigilance activities, and trade and environmental issues with potential impact on drug regulation and marketing. Available by subscription in hardcopy format, RAJ Pharma is also accessible in the Regulatory Affairs Journal database online (1993 forward). This database also includes the full text of RAJ Devices, updated bimonthly.

Was this article helpful?

0 0

Post a comment