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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.

Events

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Jan 29

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

Jan 30

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

Feb 13

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

Feb 19

Medical Device Risk Management: Prepare for the Winds of Change

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

Editor's Picks

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FDA Clears Sofregen’s Voice Augmenter

The device uses a proprietary single-use catheter delivery system.
Supremecourt

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.

NEOSE TECHNOLOGIES, INC. SHARES FALL AFTER STUDY START DELAYED BY FURTHER FDA QUESTIONS

KEYWORDS Daily International Pharma Alert
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Neose Technologies, Inc. today provided an update on its clinical development program for NE-180, the Company's long-acting, GlycoPEGylated erythropoietin for the treatment of anemia. The company has concluded the dosing and safety follow-up for its Phase I trial in Western Europe. Final analyses of pharmacokinetic data and other parameters are ongoing. NE-180 was generally well-tolerated at the doses tested, and the expected increases in reticulocytes and hemoglobin were observed in both the intravenous and subcutaneous dose groups.

BioSpace (http://www.biospace.com/news_story.aspx?StoryID=23922&full=1)