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

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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.

HUMAN GENOME REPORTS DATA FROM ALBUFERON STUDY

KEYWORDS Drug Pipeline Alert
A A

Human Genome Sciences has reported 12-week interim results from a Phase IIb clinical trial of Albuferon (albumin- interferon alpha 2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naïve to interferon alpha-based treatment regimens. The results demonstrate that Albuferon in combination with ribavirin was safe, well-tolerated and showed robust antiviral activity

The data warrant exploring the Albuferon 900-mcg and 1200-mcg doses at two-week intervals in Phase III clinical studies, noted the company.

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

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