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
Sep 25

De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For?

Sep 27

Emerging Biopharmaceutical Therapies: New Regulations, New Guidelines, New Incentives…

Sep 27

Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs

Oct 9

Medical Device Complaint Management: Follow the Outcomes for Regulatory Compliance

Oct 16

Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Editor's Picks

View all
Purple_approved_stamp

Heidelberg’s Angiography Module Approved

Physician can map and measure the thickness of the retina’s layers.
Fda_logo_black_2016

Sponsors Who Don’t Report Trial Data Could Be Hit With Fines, FDA Says

The agency will prioritize cases where sponsors have failed to submit trial registration or results for higher-risk trials.

CURAGEN INITIATES SECOND VELAFERMIN TRIAL

KEYWORDS Drug Pipeline Alert
A A

CuraGen has announced the initiation of patient dosing in a Phase II clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM).

This clinical trial, the second Phase II study of velafermin, is designed to assess the safety and efficacy 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 (BMT).

Related Products

Preparing for Expanded Clinical Trial Data Transparency - Webinar CD/Transcript

Data Integrity in Clinical Trials - Webinar CD/Transcript

Obtaining Consent in International Clinical Trials - Webinar CD/Transcript

Related Events

Safety Reporting in Global Clinical Trials: Maximizing Compliance, Minimizing Costs

Clinical Trial Risk and Performance Management Summit

Conducting Advanced Root Cause Analysis and CAPA Investigations