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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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.

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.

Home » FDA FAST-TRACKS GENITOPE'S MYVAX

FDA FAST-TRACKS GENITOPE'S MYVAX

Genitope has reported that the FDA has granted fast-track status to MyVax, a potential non-Hodgkin's lymphoma treatment. Genitope is investigating whether MyVax, a personalized immunotherapy, improves patients with follicular non-Hodgkin's lymphoma, or fNHL.

MyVax is currently in a Phase III pivotal trial involving stage 3/4 fNHL patients. Results from a Phase II trial showed nine of 21 patients remained progression-free up to 78 months post-chemotherapy.

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