Mission3 announced a major new release of its internet-based project and document management tool. The company’s software now supports non-eCTD Submissions such as 510ks, PMAs, combination products and/or study reports. The press release notes web-based authoring of scientific documents. The pricing is $2,900/month with no other setup or IT fees. A previous ClinPage article is here.

NeurAxon named Thomas Lategan VP of regulatory affairs. The Boston-area company is working on pain therapies. “Tom’s proven track record with the FDA, including two FDA advisory committee meetings and three drug approvals, as well regulatory strategy and protocol design, will be extraordinarily valuable for NeurAxon,” said Lawrence Bloch, CEO. Here’s the release.

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FDA officials will block 30 Ranbaxy products at the border. We had a short item on the FDA-Ranbaxy disagreement last week; it includes allegations about bogus HIV drugs. Yesterday’s move to keep so many products off the U.S. market is unprecedented. “With this action, we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,’‘ said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. A Daiichi Sankyo subsidiary since June, Ranbaxy had no statement to offer yesterday. This is a Bloomberg story. And what the FDA said. This letter relates to an FDA inspection of Ranbaxy facilities in March.

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The Journal of the American Medical Association (JAMA) says the FDA is slow to enforce the law regarding illegal off-label promotion of drugs. The article is only available to subscribers and is based on this GAO report on the same topic.

The Regulatory Affairs Professionals Society (RAPS) released its annual survey on salaries. The 2008 data was gathered globally for the first time and is based on more than 2,500 valid responses. Two thirds of the respondents had degrees either in the natural sciences (biology, chemistry, physics) or clinical sciences (nursing, medicine, pharmacy, dentistry, etc., etc.). Sixty percent were female. Average total compensation for those with associate degrees was $100,139; for doctorate holders, average total compensation was $186,890. The full report will soon be sold on the RAPS website. Here’s a news release.

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