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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 Approves Reconfigured OTC Asthma Inhaler

The new version uses hydrofluoroalkane propellants. 
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FDA Hits Izeen Pharma With Lengthy 483

The facility didn’t retain raw data from tests performed on different dosages of its thyroid tablets.

GLAXOSMITHKLINE AWARDED $274 MILLION HHS CONTRACT AND NOVARTIS, GOVERNMENT IN $220M FLU PACT

KEYWORDS Daily International Pharma Alert
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GlaxoSmithKline has been awarded a $274 million contract from the U.S. Department of Health and Human Services (HHS) to speed the development of new cell culture-based seasonal and pandemic influenza vaccines and to scale-up cell culture manufacturing capability at its Marietta, PA facility.

Financial News USA (http://www.financialnewsusa.com/release.php?rlsid=5040)