Big Pharma Collaborates for Inter-Company Auditing Agreement
As part of its strategic risk management of service providers, F. Hoffman-La Roche has spearheaded an initiative that standardizes and streamlines the auditing process among six collaborating sponsor companies. These six big pharma have joined forces to share the generic results of some of the cyclical, routine audits each conduct, thereby obviating the need for the other five to conduct the same audit. All have already benefited from significant cost and time savings.
Pediatric Clinical Trial Growth Stunted
The laws mandating pediatric clinical trials are set to expire later this year. In the past 10 years, the FDA has requested 760 pediatric studies. But growth has slowed as companies quickly handled the backlog. Some pediatric trial organizations have ceased doing business.
Europe Anticipates Surge in Pediatric Drug R&D
Drug companies, contract research organizations (CROs), regulators, and patient advocates are braced for the impact of the European Commission's new pediatric regulation, which came into force last month. More than 50% of medicines given to children in Europe have never been put through pediatric clinical trials, and have not been specifically approved for pediatric use.
Eye On: Diarrhea
Diarrhea, defined as loose, watery and frequent bowel movements, is considered chronic when it persists for more than four weeks. In adults, diarrhea is usually mild and resolves quickly without complications, but in infants and children younger than age 3, diarrhea can rapidly lead to dehydration.
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