Newsletters

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.

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 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.