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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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Developing Pharmaceutical Investigational Brochures & Annual Reports: Secrets to Practical Succes...

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Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?

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Building a World-Class Drug Supply Chain: Tips for Compliance and Digital Transformation

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Medical Device Risk Management: Prepare for the Winds of Change

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Medical Device Complaint Management: Escape the Labyrinth

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Conducting Advanced Root Cause Analysis and CAPA Investigations

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Allergan, St. Regis Tribe Seek SCOTUS Review of Sovereign Immunity Case

The Patent Trial and Appeal Board ruled last year that Native American tribes cannot use sovereign immunity as a defense against inter partes reviews.

SOLVAY JOINS ABBOTT/ASTRAZENECA DEAL TO DEVELOP FENOFIBRATE IN THE U.S.

KEYWORDS Daily International Pharma Alert
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Pharmaceutical groups AstraZeneca and Abbott announced that they will jointly develop and commercialize in the United States a fixed-dose combination product containing two lipid-regulating agents. This new combination product will be promoted in the U.S. by both companies, with a target 2009 for regulatory submission. The new product will combine Crestor (AstraZeneca's rosuvastatin) with either TriCor (Solvay's fenofibrate, licensed to Abbott for the U.S.) or a next-generation fenofibrate developed by Abbott and Solvay as a new lipid-regulating agent.

In addition to this new fixed-dose combination in the U.S., Solvay has several other products in development. The next one out of this string of projects is expected to be Synordia (previously known as Dualthys), a fixed-dose combination of an oral antidiabetic (metformin) and fenofibrate for Type II diabetic patients, due to be submitted for European Union registration this summer.