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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.
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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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Nov 27

Returning Plain-Language Summaries to Research Participants: Best Practices for Sponsors and the…

Nov 28

REMS: Requirements, Regulation, and Enforcement — Evolution from Safety Program to Enforcement Tool

Nov 29

Chinese Medicine: The Dangers of Deployment — The Impact on Pharmaceutical Regulatory and…

Dec 4

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Dec 5

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies: DAIA Will be a Game-Changer

Dec 6

SOPs and Policies for the 21st Century: Why Less is More

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Beckton Dickinson Gets Clearance for CPO Detection Test

The test can deliver results in less than 36 hours.
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FDA Asked How to Unblind Blood Cancer Trials

Drugmakers asked the agency to clearly state how it wants sponsors to “un-blind” information.
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GI Dynamics Gets FDA OK for Clinical Trial

Aug. 27, 2012
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GI Dynamics announced approval from the FDA to skip the pilot trial usually required for medical devices, allowing the company to move directly into a pivotal clinical trial of its lead product, a device for the treatment of obese patients who have uncontrolled Type 2 diabetes.
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