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Gmp-inspection-preparation-checklist-130x160

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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May 30

Cutting the Costs of Clinical Trial Subject Recruitment: Insights into Patient Outreach: Traditio...

May 31

FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

Jun 5

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

Jun 5

Appendix M of the NIH Guidelines: Reporting Requirements and Best Practices

Jun 6

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Jun 7

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

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Congress

Stakeholders Urge Congress to Update Clinical Laboratory Diagnostics Legislation

The letter to lawmakers cites an urgent need to reform regulations covering laboratory developed tests and in vitro diagnostics.
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Seniors Paying More for Generics Through Medicare Part D, Study Finds

The higher cost sharing did not correspond with an increase in the underlying price of generic drugs, Avalere said.

VAXGEN RAISES $79M THROUGH SALE OF INTEREST IN OVERSEAS BIOPHARMACEUTICAL MANUFACTURING FACILITY

KEYWORDS Daily International Pharma Alert
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VaxGen, Inc. announced today that it has realized gross proceeds of approximately $79.0 million through the sale of a portion of its common shares in Celltrion, Inc. VaxGen also granted the purchasers an exclusive option to acquire the remainder of its Celltrion shares by December 31, 2006.

Yahoo News (http://biz.yahoo.com/prnews/060629/sfth045.html?.v=61)

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Appendix M of the NIH Guidelines: Reporting Requirements and Best Practices

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