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.
"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."
The heparin tragedy was not surprising in light of the Government Accounting Officeï¿½s (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 .ï¿½
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.
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 that the ICH eCTD specification document (version 3.2) provides recommendations on how you should name your files?"
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.