Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Abbott Issues Firmware Update for Implantable Cardiac Devices
The upgrade also introduces a device-based battery performance feature to monitor the battery for abnormal behavior and vibrate to alert the patient if any issues are detected.
Senators Ask Gottlieb to Justify Restrictions on Loperamide
The FDA policy would limit over-the-counter packs to eight pills.
UK Health Officials Ask Vertex to Wrap Up Orkambi Pricing Negotiations
The National Health Service said it will refuse to cover the drug unless Vertex lowers the price. Read More
International Devices and Diagnostics Monitor
Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More
Senators Seek Lower Prices for Combination Naloxone Products
The cost of the hand-held auto-injector form of the drug, Evzio, has increased from $690 for a two-pack in 2014 to $4,000, according to Michigan senators Debbie Stabenow and Gary Peters. Read More
483sOnline.com Your Personal Pre-inspection Toolkit
Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
Data Integrity in the EU: Requirements for Quality Management Systems
You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in.
510(k) Change Analysis: Complying with FDA’s Final Guidances
Order your copy of the 510(k) Change Analysis brief for step-by-step instruction on deciding whether you need to submit a new 510(k) if you change an existing device.
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products.
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