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Drug GMP Report

Drug GMP ReportDrug GMP Report

For over 20 years, drug manufacturers have relied on Drug GMP Report for the latest on FDA’s interpretation and enforcement of cGMPs and Quality Systems Regulation — information you need to stay in compliance. Each monthly issue brings you the latest on FDA enforcement trends and warning letters, track and trace developments, international regulations and more. You’ll also get the latest on inspection hot spots, data integrity issues, EU pharmacovigilance initiatives, harmonization efforts and evolving trends in drug GMP 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 many more.

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Drug Industry Daily

DIDDrug Industry Daily

This daily electronic briefing delivers coverage of developments at the FDA, FTC, HHS and other key agencies and decision-making bodies that affect the pharmaceutical industry around the world. Each issue gives you the most up-to-date news on top issues, such as patent exclusivity, market globalization enforcement, EU pharmacovigilance, new inspection trends, advertising practices, FDA warning letters, recalls, approvals and more. It’s the fastest, most reliable way to make sure you’re an industry expert.

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International Devices & Diagnostics Monitor

International Devices & Diagnostics MonitorInternational Devices & Diagnostics Monitor

International Devices & Diagnostics Monitor (IDDM) is a one-stop resource that brings you a complete, global picture of the medical device regulations that affect your business. Nowhere else will you find a more comprehensive collection of all the regulatory changes in the US, EU, Asia, Latin America, the Middle East, Australia and the rest of the world. Your subscription includes a weekly newsletter to keep you up to date with global regulations as changes happen, including complete text of all government documents.

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International Pharmaceutical Regulatory Monitor

IPRMInternational Pharmaceutical Regulatory Monitor

For over 40 years, International Pharmaceutical Regulatory Monitor has helped drugmakers' stay on top of new and changing pharma regulations around the world. This monthly newsletter tracks relevant topics — counterfeiting, marketing authorization, joint inspections, changes in international patent protections, transparency in clinical trials, unannounced inspections — in the markets where you need to stay compliant. IPRM covers long-established regulatory leaders, the FDA, European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other key organizations around the globe. IPRM also covers Latin America, Asia, Africa and other growing markets. In each issue, you get English-language texts of important, hard-to-obtain proposals, regulations, guidelines and other documents to help ensure speedy reviews of your regulatory submissions and success at home and abroad.

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The GMP Letter

The GMP LetterThe GMP Letter

For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance. Each monthly issue brings you updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions. You’ll also get the latest on cybersecurity, recalls, CAPAs, MDR reporting and more. And you’ll get links to Form 483s, warning letters, closeout letters, FDA policy notices and other reports to ensure your quality assurance efforts are a success.

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