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.

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 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.