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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.

GLAXOSMITHKLINE PROFITS SURGE IN FIRST QUARTER

KEYWORDS Daily International Pharma Alert
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The GlaxoSmithKline headquarters compound in west London photographed, in January 2002. British pharmaceuticals giant GlaxoSmithKline posted a 27-percent increase in first-quarter pre-tax profits to 2.17 billion pounds (3.12 billion euros, 3.87 billion dollars) compared with the same period last year.

TODAYonline (http://www.todayonline.com/articles/115131.asp)