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Support : Publications : Chronolog Archives
: March/April 2005
FDAnews for Regulatory Information
A new database FDAnews (File 182/FDAN), the premier provider of domestic and international regulatory, legislative and business news and information for industries regulated by the U.S. Food
and Drug Administration and The European Commission, is coming soon to Dialog and Dialog DataStar. Subscription-based options will be available on Dialog NewsEdge.
FDANews on Dialog and Dialog DataStar (File 182/FDAN)
Newsletters in FDAnews help you comply with international standards and FDA's complex and
ever-changing regulations so that you can get your products to market faster and boost profits.
The database includes seven newsletters with topics ranging from ethics of clinical trials (Clinical Trials Advisor) and technical quality control issues (Drug GMP Report Monthly) to briefings from Capitol Hill and U.S. government agencies on FDA appropriations, warnings and recalls (Drug Industry Daily). The generic drug industry, including cooperative agreements, is also covered (Generic Line), and concise summaries report FDA regulatory changes and key legislation that affects prescription and OTC drugs (Washington Drug Letter). Additional insights for complying with the complex and still-evolving 21 CFR Part 11 rule (Part 11 Compliance Report) and help in obtaining biodefense grants and contracts make FDAnews a database for all of your regulatory and compliance needs.
Information for FDAnews is drawn from press releases and government Web sites, as well as from sources within the FDA, on Capitol Hill and within the industry. Updates range from daily, twice weekly and monthly depending on the newsletter.
FDANews on Dialog NewsEdge
The seven newsletters in File 182/FDAN are also available on Dialog NewsEdge. In addition to these subscription-based newsletters, seven other titles are included in Dialog NewsEdge as Topics (DNE, Topics). Topics range from global pharmaceutical and medical device news, reports on new drugs in development from the FDAnews Drug Pipeline Alert and quick analysis of developments affecting pharmaceutical companies in emerging markets around the world (Daily International Pharma Alert). Other areas of interest relate to nutraceuticals (Nutraceutical Weekly Bulletin), corporate mergers and acquisitions and conferences and events. This information is also covered in File 182/FDAN.
Following are brief summaries of the various newsletters.
FDAnews Drug Daily Bulletin — provides FDA regulatory, legislative and business news briefs in the pharmaceutical and biologics industries, plus a snapshot of international news relevant to your business.
FDAnews Device Daily Bulletin — lets you keep track of developments in the medical device industry, plus a snapshot of international news affecting the medical device industry.
FDAnews Drug Pipeline Alert — provides the latest intelligence on R&D of new drugs in development, including U.S. and international clinical trials, drug applications and co-development activities.
Daily International Pharma Alert — contains analysis of developments affecting pharmaceutical companies around the world.
FDAnews Nutraceutical Weekly Bulletin — covers the latest in FDA regulatory issues, corporate mergers and acquisitions, technology developments and legislation affecting the global nutraceutical industry.
FDAnews Drug Conference Calendar — contains a comprehensive listing of pharmaceutical conferences in the U.S. and around the world.
FDAnews Device Conference Calendar — contains a comprehensive listing of upcoming medical device events.
The BioDefense Funding Report — a biweekly newsletter that helps you find and win biodefense grants and contracts from basic research to medical devices to protective devices and drugs. It is a quick, cost-effective way to pinpoint opportunities and get to the source of the funds without wasting valuable time and resources.
Clinical Trials Advisor — contains the latest regulatory and international news, as well as practical advice for maximizing your clinical investments. All areas of clinical trials are covered from ethics to information technology, training to patient recruitment, accreditation to disclosure.
Devices & Diagnostics Letter — a weekly publication helpful to device and diagnostics industries that need to stay in compliance and avoid costly design and production mistakes. Each issue provides the latest regulatory news, including Part 11 compliance, software validation rules and other pre- and post-market requirements, and tells you how to slash research time, speed your products through the approval process and pass a facility inspection.
Drug GMP Report Monthly — provides in-depth coverage of technical quality control issues that affect your drug development and production processes. Each issue contains concise, easy-to-read explanations of key regulatory trends and advice to make FDA regulatory compliance easier. You will be able to stay up to date on the latest inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.
Drug Industry Daily — a daily briefing on happenings on Capitol Hill and at other key agencies and decision-making bodies that affect the pharmaceutical industry. Each issue gives you hard reporting on top issues, such as patent exclusivity, medication errors, program funding, FDA appropriations, bioterrorism, warnings, recalls, approvals and more.
The Food & Drug Letter — a biweekly publication providing reliable, in-depth analysis of how FDAÕs regulations and procedures will affect your current decisions and long-term plans and gives you in-depth interpretation to tell you why FDA is making or proposing revisions.
Generic Line — devoted exclusively to the generic drug industry. Issues cover growing interaction among brand-name companies and generic makers, including the latest cooperative agreements, plus crucial business, regulatory, and legislative changes affecting your business decisions.
The GMP Letter — provides monthly informed reports of key regulatory developments, tips on what you can do to prepare for FDA inspections, proven ways to improve design control procedures and tips on creating more effective GMP training programs.
Part 11 Compliance Report — a biweekly newsletter providing definitive insights for complying with the complex and still-evolving 21 CFR Part 11 rule. Each issue contains comprehensive coverage of requirements for electronic submissions and signatures, guidance document interpretations, implementation best practices, FDA enforcement actions and more.
Pharmaceutical Corporate Compliance Report — a biweekly publication providing insight into the full range of compliance risks and responsibilities. From drug pricing for government purchasers to patient privacy, from corporate accounting and financial reporting to human subject research protection, non-FDA compliance concerns are increasing daily.
Washington Drug Letter — provides concise summaries of FDA regulatory changes and key legislation that affects prescription and OTC drugs. Each weekly issue brings you up to date on pre-approval and post-approval issues that directly impact your operation, such as: electronic submissions, pediatric studies, user fees and NDA submissions, drug re-importation, post-market surveillance priorities, GMPs, international harmonization and more.
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