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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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Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

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

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Editor's Picks

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MHRA Recalls Digital Pregnancy Tests

The recall affected one lot involving 58,000 tests distributed in the UK. 
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Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force.

CYTIMMUNE TO BEGIN CYT-6091 TRIAL

KEYWORDS Drug Pipeline Alert
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CytImmune Sciences has received notification from the FDA to begin a Phase I clinical trial to evaluate the safety, pharmacokinetics and clinical benefit of its lead drug candidate, CYT-6091, a TNF-bearing pegylated colloidal gold nanoparticle, in patients with advanced cancer.

Up to 42 patients with advanced cancer whose disease has failed to respond to existing therapies or where no approved therapy is available may be enrolled in the study. The intravenously administered, dose- escalation study will be conducted at the National Cancer Institute in Bethesda, Md.