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Clinical Trials Advisor

Clinical Trials Advisor is the one-stop resource for clinical research sponsors and sites investigating novel drugs and medical devices. Turn to CTA for timely information and advice on how to gain new business, improve operations and stay in compliance with the FDA’s GCP requirements. Each biweekly issue offers practical advice on maximizing your clinical investments, updates on the latest regulatory and international news, and more. Plus, it provides links to important documents — such as guidances, warning letters and Form 483s — from the FDA, foreign regulators and global organizations.

Devices & Diagnostics Letter

For 40 years, Devices & Diagnostics Letter has been a must-read for industry leaders who need to stay in compliance and avoid costly design and production mistakes. Published weekly, each issue provides the latest regulatory news, including Part 11 compliance, software validation rules and other pre- and postmarket requirements. It also tells you how to slash research time, speed your products through the approval process and pass facility inspections. 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 and GAO reports — that make it easy to come up to speed on changes in FDA regulations and expectations, ensuring a smooth transition.

Drug GMP Report

For two decades, Drug GMP Report has provided thorough analysis and interpretation of current good manufacturing practice (cGMP) 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 international harmonization efforts, electronic data requirements and evolving trends in cGMP enforcement. Plus, every issue, you get links to critical documents such as draft and final guidances, Form 483s, warning letters, proposed rules, full text of proposed legislation and a host of others.

Drug Industry Daily

This daily electronic briefing delivers coverage of what’s happening on Capitol Hill and at the FDA, FTC, HHS 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, market globalization, biosimilar development, advertising, program funding, FDA appropriations, warning letters, recalls, approvals and more. Written by FDAnews’ veteran staff of reporters, you get the latest news 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.

Generic Line

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.

International Medical Device Regulatory Monitor

For more than two decades, the International Medical Device Regulatory Monitor has helped devicemakers stay on top of regulatory developments around the world. Not only will you learn about updates to device and diagnostic regulations in the EU, Canada, Japan and Australia, but you’ll find out what governments in emerging markets like Brazil, Russia, India and China — as well as countries in Africa, the Middle East and Southeast Asia — are doing to increase the level of device regulatory oversight. In today’s increasingly global marketplace, IMDRM will save you hundreds of hours of research time and thousands of dollars to ensure that your launches are successful and your growth continues in the right markets. Each month’s issue includes links to official English-language texts of key, hard-to-obtain proposals, regulations, directives, guidances and other regulatory documents.

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor has been a ‘must read’ for pharma professionals for more than 40 years, bringing them the latest changes in rules and standards at the FDA, European Medicines Agency, Health Canada, Australia's TGA, International Conference on Harmonisation and other key organizations. And as the global marketplace has expanded to markets in Latin America, Asia and Africa, IPRM has kept readers informed of regulatory developments in those regions as well. In each issue, you get actual English-language texts of important, hard-to-obtain proposals, regulations, guidances and other documents to help ensure speedy reviews of your regulatory submissions and success at home and abroad.

The GMP Letter

For 30 years, medical device manufacturers worldwide have relied on The GMP Letter to comply with the 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 the audits revealed. You also get links to Form 483s, warning letters, closeout letters, FDA policy notices and many other reports to help make your quality assurance efforts a success.

Washington Drug Letter

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 U.S. Congress and agencies like FDA, 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, full text of proposed legislation, GAO reports and more. NEW 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.

FDAnews Device Daily Bulletin

Each day you'll receive targeted FDA regulatory, legislative and business news briefs in the pharmaceutical and biologics industries. Plus, you'll get a snapshot of international news relevant to your business. In just a few minutes you can scan major headlines and click through to read the stories you want. Sign up today and receive your first FDAnews Drug Daily Bulletin the next business day. This subscription includes a weekly email alert, FDAnews' Pharma Solution of the Week, highlighting one problem and one solution in the pharmaceutical arena.

QMN Weekly Bulletin

By reading the Quality Management Network's QMN Weekly Bulletin you can keep track of the latest from the FDA, Congress and industry experts in the world of cGMP's for pharmaceutical and medical device manufacturers. Each issue delivers crucial information on regulatory changes and inspection trends, as well as a wrap-up of the major quality management news from around the world. Sign up today and start receiving The QMN Weekly Bulletin.

FDAnews Drug Daily Bulletin

Each day you'll receive targeted FDA regulatory, legislative and business news briefs in the pharmaceutical and biologics industries. Plus, you'll get a snapshot of international news relevant to your business. In just a few minutes you can scan major headlines and click through to read the stories you want. Sign up today and receive your first FDAnews Drug Daily Bulletin the next business day. This subscription includes a weekly email alert, FDAnews' Pharma Solution of the Week, highlighting one problem and one solution in the pharmaceutical arena.

Clinical Trial Magnifier Weekly

Clinical Trial Magnifier Weekly monitors 150,000 trials in 185 countries around the world every week and reports to you the fresh changes. By sifting through tens of thousands of records, we’re able to extract just the information you need. You’ll be able to scan all the changes and drill down using links in the newsletter to focus on the ones that are important, saving you countless hours of effort.

Executive Briefing

Designed by the editors of The Food & Drug Letter for busy executives who have to stay up to date on multiple, complicated issues, The Executive Briefing Series brings together tested and practical advice and information from experts around the world. FDAnews’ staff finds the right expert on the right topic and culls their knowledge to bring you on-point summaries each month. Executive Briefing Series readers call it “invaluable” and “unique” and praise it for its timely and thorough coverage of key topics.