Newsletters

Clinical Trials Advisor helps clinical research sponsors and clinical sites researching drugs and medical devices gain new business, improve operations and keep in compliance with the FDA’s GCP requirements. In every biweekly issue, you get practical advice on maximizing your clinical investments, updates on the latest regulatory and international news, reporting and training applicable to clinical trials, and more. Plus, it provides links to important documents from the FDA and international organizations, such as guidances, warning letters, Form 483s, and more.

For over 35 years, Devices & Diagnostics Letter has been a must-read for leaders in the device and diagnostics industries who need to stay in compliance and avoid costly design and production mistakes. Each weekly 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, pass facility inspections, and more. In every issue, you get links to key documents, such as draft and final guidances, warning letters, proposed and final rules, closeout letters, full texts of proposed legislation, GAO reports, and many others.

For more than 15 years, Drug GMP Report has provided thorough analysis and interpretation of ever-changing good manufacturing practice (GMP) regulations, FDA enforcement trends and warning letters, international regulations and more. It's like receiving a monthly executive briefing packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement. Plus, every issue, you get links to documents such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

This daily electronic briefing delivers coverage of what's happening on Capitol Hill and at the FDA, FTC, HHS, NIH and 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, DTC advertising, medication errors, program funding, FDA appropriations, bioterrorism, warning letters, recalls, approvals and more. Written by FDAnews' veteran staff of reporters, you get the news as it happens with the added perspective that only seasoned reporters can provide. It's the fastest, most reliable way to make sure you're an industry expert.

This new monthly series by the editors of The Food & Drug Letter will give you in-depth reporting and analysis on a variety of topics that impact your industry and decision making.

For over 25 years, the Generic Line has been the leading resource for accurate, up-to-date analysis of FDA policies affecting generic drugs and drug patents. With a new biosimilars approval path, blockbuster drugs facing patent cliffs, and the FTC trying to stop pay-for-delay agreements, there's never been a more critical time to subscribe. With every issue, you get links to additional key documents, such as FDA guidances, warning letters, rules, full texts of proposed legislation and much more.

The International Medical Device Regulatory Monitor helps devicemakers stay on top of recent regulatory actions around the world – in emerging markets like the EU, Brazil, Russia, China, Turkey and others – ensuring that your launches are successful and your growth continues in the right markets. With it, you'll save hundreds of hours of research time and thousands of dollars, plus stay far ahead of your competition. In every issue, you also get complete official English-language texts of key, hard-to-obtain proposals, regulations, directives, guidances and other regulatory documents.

Every month for over 35 years, International Pharmaceutical Regulatory Monitor has kept pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere. In every issue, you get actual, full official English-language texts of important, hard-to-obtain proposals, regulations, rules, directives, guidances and other documents, to help you prepare better-documented, properly formatted drug applications for fastest processing.

For 30 years, medical device manufacturers worldwide have relied on The GMP Letter to comply with FDA's interpretation and enforcement of cGMPs and the Quality System Regulation (QSR). In each issue, you get an update on regulations and guidances and learn which companies the FDA has inspected and what they've found. You also get links to 483s, warning letters, closeout letters, FDA policy notices, and many other reports to help make your quality assurance efforts a success.

For more than 40 years, WDL’s team of journalists has been the eyes and ears of pharmaceutical executives in Washington when it comes to the US Congress and agencies like FDA, NIH, CMS, DOJ, FTC, and the HHS Office of the Inspector General. WDL covers enforcement activities, rulemaking, guidance development, court cases and precedents, congressional actions and new laws affecting the industry. In every issue, you get links to important documents, such as FDA letters, guidances, rules, full texts of proposed legislation, GAO reports and more. NEW 2013 FEATURES: You will now get weekly information on new warning letters, what is buzzing at the FDA, the FDA calendar, the most recent FOIA requests and current court and legislative actions.