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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 14

Conducting Advanced Root Cause Analysis and CAPA Investigations

Nov 14

Clinical Trial Risk and Performance Management Summit

Nov 14

The 510(k) Process: A Whirlwind of Change, Challenges, and Opportunities

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

Editor's Picks

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FDA Extends UDI Deadlines Another Two Years for Class I, Unclassified Devices

The FDA said the new compliance date is Sept. 24, 2020.
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United Exchange Warned for Inaccurate Listing Information

The agency had previously pointed out the deficiency in a February letter to the company.
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FDA to Spend up to $182,000 on Social Media Tool to Shape, Monitor Communications

Sept. 23, 2013
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In July, the FDA announced that it was accepting contracts for companies interested in helping the agency monitor social media tools for comments about the agency’s performance. The FDA more recently announced that it had awarded that contract to a software development company called IB5k.
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