Menu
View Cart  

Recommended Products

Visit Store
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.
Biological-risk-eval-and-mngmnt-for-md-130x160

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

View All
May 24

Start Your Quality 4.0 Journey Today!: Achieve Quality and Operational Excellence Through Digital...

May 30

Cutting the Costs of Clinical Trial Subject Recruitment: Insights into Patient Outreach: Traditio...

May 31

FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

Jun 5

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Jun 5

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

Jun 6

10 Sure-Fire Tips for Developing a Document Management System Any Investigator Would Love

Editor's Picks

View all
Redwarningstamp

Complaint Handling, Process Controls Lacking at Battery Maker Alpha Source

Complaint records lacked adequate documentation of the root cause or corrective actions taken.
Fda_logo_blue_2016

FDA Approves Treatment for Thrombocytopenia

Both dosage levels of Doptelet led to a higher proportion of patients with increased platelet counts.

CURAGEN BEGINS SECOND CLINICAL TRIAL WITH VELAFERMIN

KEYWORDS Drug Pipeline Alert
A A

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.

Related Products

Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy

Reporting Failed Trial Data: New Rules for ClinicalTrials.gov - Webinar CD/Transcript

Best Practices for Managing Clinical Trial Materials - Webinar CD/Transcript

Related Events

Cutting the Costs of Clinical Trial Subject Recruitment: Insights into Patient Outreach: Traditional vs. Digital

The Real Impact of Common Rule in 2018: Understanding Nuances, Facilitating Compliance…

Inside FDA’s Oncology Center of Excellence: What Regulatory & Quality Professionals Need to Know