Newsletters

Clinical Trials Advisor is devoted to helping pharmaceutical manufacturers, clinical researchers, IRBs and investigators improve clinical trial operations and GCP compliance. You'll get the latest regulatory and international news, as well as practical advice for maximizing your clinical investments. No other resource provides such valuable reporting and training applicable to every area of clinical trials. From ethics to information technology, training to patient recruitment, accreditation to disclosure — if it impacts clinical trials, CTA covers it.

This is 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 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.

This gives you in-depth coverage of technical quality control issues that affect your drug development and production processes. Each issue provides concise, easy-to-read explanations of key regulatory trends and advice to make FDA regulatory compliance easier. You'll 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.

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.

Get on the inside track of how $15 billion of branded drugs coming off patent in the next five years will affect your firm. Use Generic Line, the only newsletter devoted exclusively to the generic drug industry, to stay on top of the growing interaction among brand-name companies and generic makers, including the latest cooperative agreements, plus all the crucial business, regulatory, and legislative changes affecting your business decisions.

Every month you get a comprehensive briefing on the latest regulatory developments around the world, including the U.S., Europe, Latin America, Asia, Canada, Australia and more. Plus you get actual full, official English-language texts of important, hard-to-obtain proposals, regulations, rules, directives, guidances and other documents to keep you completely up-to-date on significant developments in medical device regulatory policies worldwide. Save hours on research time and overcome barriers to application approval.

Stay on top of key changes in pharmaceutical regulation around the world with this monthly resource for rules and standards flowing 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 addition to a comprehensive briefing, 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.

The Food & Drug Letter provides reliable, in-depth analysis of how FDA's 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. Helps you chart your course for electronic signatures, drug and device GMPs, labeling, FDA inspections and much more.

Use The GMP Letter to stay on top of FDA's interpretation and enforcement of the Quality System Regulation (QSR) and know which changes your firm must make to comply. Each month, The GMP Letter provides an informed report 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.

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 reimportation, post-market surveillance priorities, GMPs, international harmonization and more.