July 2008

Feature Article:

Effective Records - Get Them Right by Getting Proactive with Vendors and Suppliers

For Pharmaceuticals:

An Analysis of Heparin, Accountability and Pre-emption: Where Are We Now?

For Medical Device:

Summary of Cambashi and FDANews Research Report

For Blood & Biologics:

Blood Substitute�s Effectiveness and Safety Addressed in Large Clinical Trial

One Out of 10,000 Drugs:

A Medicine�s Gamble in the Marketplace

Did You Know?

ICH eCTD Specification Recommendations for Naming Files

Webinar:

Tools to Circumvent Pitfalls on the Path to Your IND/NDA Milestones



Upcoming Events

Glossary

Submissions

Editorial Staff

Feature Article: Effective Records - Get Them Right by Getting Proactive with Vendors and Suppliers Poor records--and poor management of good records--can trigger needless costs, penalties, and public embarrassment for FDA-regulated companies. And if managing your own records isn't challenging enough, FDA holds you equally responsible for ensuring the quality of records generated by your suppliers, contractors, and vendors.

To protect the integrity of your regulated products and your company's reputation, you must be proactive and continuously monitor the activities and records of each link along your supply chain, including suppliers and vendors whose activities may affect the safety and efficacy of your final product. Even if FDA does not directly regulate all of your suppliers, it's ultimately your responsibility to ensure their records accurately reflect what's happening at their sites.




For Medical Device: Summary of Cambashi and FDANews Research Report - Risk Management - Best Practices for Medical Device Profitability

"Risk management takes multiple forms. The most obvious view of risk management involves risk to the patients using the device, but the risk to the business itself is also a critical consideration. In theory, risk management for patient safety should also reduce the overall risk for the company and lead to a higher probability of profits."


For Pharmaceuticals: An Analysis of Heparin, Accountability and Pre-emption: Where Are We Now?

The heparin tragedy was not surprising in light of the Government Accounting Office�s (GAO) reports that the FDA has been lacking in its ability to control foreign inspections of both device and drug manufacturers. The most recent GAO reports of late, in 2007 and 2008, demonstrate a continued lack of FDA control over foreign manufacturing operations for nearly 10 years .�


For Blood & Biologics: Blood Substitute�s Effectiveness and Safety Addressed in Large Clinical Trial

A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.

Published in the June edition of the Journal of Trauma®, this study is the first Phase III trial to compare a blood substitute to regular blood and was conducted at 46 sites in the United States, Europe and South Africa.


One Out of 10,000 Drugs: A Medicine�s Gamble in the Marketplace

According to an ongoing study at Tufts, the average cost of bringing a drugt to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1billion.


Did You Know? ICH eCTD Specification Recommendations for Naming Files

"Did you know that the ICH eCTD specification document (version 3.2) provides recommendations on how you should name your files?"



Webinar: Tools to Circumvent Pitfalls on the Path to Your IND/NDA Milestones

The Tools to Circumvent Pitfalls on the Path to your IND/NDA webinar focuses on avoiding the loss of critical time and money, by presenting a comprehensive strategic plan to lead life science professionals through the drug development maze with foresight, confidence and control.




If you would like to subscribe to GxP Lifeline, forward it to a colleague or unsubscribe, please click here.

Return to Top