Newsletters

For over 35 years, Device & 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.

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.

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 more than 30 years, The Food & Drug Letter has been the #1 resource for pharmaceutical executives who need regular top-level overviews to stay fully informed and up-to-date on the drug industry's issues and opportunities. In fact, it’s like having a trusted consultant who can summarize major issues with an executive-level perspective — covering just one topic per issue — to give you a clear idea of where the FDA is heading and what your options are for staying compliant, competitive and profitable.

For over 40 years, pharma professionals have turned to Washington Drug Letter (WDL) to learn about the week’s key events and what they mean for the pharmaceutical and biologics industries. Subscribers call WDL "invaluable," with its concise coverage of the FDA's and other regulators' actions, congressional legislation and hearings, federal and state court decisions, and industry moves to influence government policies and procedures. In every issue, you get links to important documents, such as FDA letters, guidances, warning letters and 483s, rules, full texts of proposed legislation, GAO reports and more.