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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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Aug 15

Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers

Aug 16

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead

Aug 22

Corporate Compliance & Liability: What Medical Product Professionals Need to Know

Aug 23

What CDER Can and Can’t Do: An Inside Look from an Agency Official

Aug 23

Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

Sep 10

Mastering EU Medical Device Regulation

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Procleix’s Zika Assay Earns FDA Approval for Use With Panther System

The assay is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products.
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FDA Plans Study of Risk Information in Direct-to-Consumer Print Ads

The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each.

CURAGEN BEGINS SECOND CLINICAL TRIAL WITH VELAFERMIN

KEYWORDS Drug Pipeline Alert
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CuraGen has begun its second Phase II study of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation.

CuraGen said that it expects the primary OM efficacy and safety results will be available by the third quarter of 2007, and the one year follow-up data will be available in the third quarter of 2008.

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Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

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