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DID YOU KNOW...

That under key FDA regulations, requirements pertaining to nonconformance disposition are directly related to CAPA requirements?
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Especially for Pharmaceuticals

Will FDA?s new clinical investigations guidance positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry?
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Especially for Pharmaceuticals


Especially for Medical Devices

A recent FDA report lists the challenges of monitoring and assessing the safety of medical devices after they’ve been sold.
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Especially for Medical Devices



Especially for Blood / Biologics

The FDA issued a total of 36 product recalls of HCT/Ps last year and shut down two tissue-recovery firms because of serious Good Tissue Practice violations.
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Especially for Blood / Biologics



Study: High-Performing Manufacturers Enforce Enterprise-Wide Quality Procedures as Top Business Strategy

A recent survey of 176 manufacturers throughout the world shows that more than half of best-in-class companies enforce enterprise-wide quality procedures as a top business strategy.

These high-performing manufacturers take a more disciplined approach toward enforcing quality procedures, and are farther along in closing the quality loop than poorer performing companies, according to a benchmark study by the Aberdeen Group, a leading research group for the technology-driven value chain.

The study also shows that manufacturers are overcoming challenges by incorporating metrics, implementing corporate education programs, and embedding corrective action programs into SOPs.
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Stagnation vs. Innovation: FDA?s Critical Path Initiative

Americans born in the 1940s marvel at the advances made in modern medicine since their birth. Vaccines, penicillin, antibiotics, CAT scans, the unraveling of the human genome and cancer drugs have led the march of medical progress into the 21st century. And with so many achievements in medicine during the last 70 years, it is not surprising that Americans expect this trend to continue. But such expectations may be unrealistic. The high costs of drug and medical device development are hampering the industry. New drug approvals have flattened in recent years, in spite of statistics that cite expenditures of the public and private sectors in excess of $100 billion for medical research.

Recognizing the disconnect between funding and outcomes, in 2004 the FDA launched the Critical Path Initiative to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.

?We all agree that moving candidate products from discovery into the practice of medicine is a long and costly process,? says Dr. Rachel Behrman, director of the Office of Critical Path Programs in the office of the FDA commissioner. Dr. Behrman has been in charge of the Critical Path Office since 2004 and has helped spread the Critical Path message about the need for a nationwide effort to build on recent achievements in biomedical research.
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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

How to Prepare for a Systems-Based Inspection (Center for Professional Innovation and Education)
(July 30-31, 2007)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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Editorial Staff

We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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Editorial Staff

GxP Lifeline
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