The FDA is soliciting industry input for a “quality by design” initiative, FDA News reports. Here’s the federal notice.

The Associated Press has tabulated the time needed for the FDA to send warning letters over the illegal promotion of off-label uses of prescription drugs. It takes the agency seven months to complete the process. “During that time, a lot prescriptions can be written,” the wire service notes in this article.

Clinilabs has been certified by Mortara to submit electrocardiograms (ECG) and thorough QT studies in its format. “Clinilabs is poised to provide sponsors with the same world-class quality in ECG data management that both large pharmaceutical and biotechnology companies have grown accustomed to receiving from us as a core lab in the CNS arena since 2002,” stated president and CEO Gary Zammit. Here’s the release and a recent ClinPage profile.

Can “just in time” ideas from the world of manufacturing be used in clinical trials? Pharmatech Research Network, based in Denver, thinks so. The firm manages clinical sites and has recently inked contracts with five sponsors to find 500 oncology patients. “The recent activity in new business has been a true testament to the acceptance of the just-in-time enrollment strategy. Study sponsors and sites have praised the new enrollment methodology, as cancer patients are treated in a more efficient manner and sponsors see their trials completed in a shorter time frame,” says Pharmatech CEO Matthew Wiener. Here’s the release.

PHT’s Valdo Arnera was named to the PharmaVoice 100, a list of the most inspiring people in the life sciences. Arnera is general manager of the electronic patient diary company’s European operations.

India has not reported any adverse events to international authorities at the World Health Organization in three years. That’s the allegation of a consultant. “The system [of pharmacovigilance] has failed in India. There is lack of training, medical assessors in drug controller’s office, insufficient funds and no motivation at all,” says Symogen managing director Pipasha Biswas, whose company provides pharmacovigilance-related services. Here’s the release.

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