Octagon Research issued a release noting that it is helping the Clinical Data Interchange Standards Consortium (CDISC) train the FDA as part of a two-year contract to train agency personnel on regulatory submissions and data standards. Fred Wood, principal consultant and lead of the data standards consulting group at Octagon stated: “Octagon team members have had many interactions with FDA representatives via CDISC teams and the CDISC organization as a whole. We see many of the problems the reviewers have with submitted data, and also see many of the issues sponsors have meeting eCTD Study Data Specifications. This opportunity will give us the ability to help facilitate the bi-directional flow of information between sponsors and reviewers.”

Akaza Research released a new version of its open source software for electronic data capture. The latest version of the system has more features related to monitoring, query management, multivariate edit checks, improved scaleability, and simpler case report form upload. Here’s a release.

The Kaiser foundation has this roundup of a key Supreme Court case to be heard this fall, when the justices are expected to ban anti-industry pharmaceutical product liability lawsuits (as they already have for medical device makers). Anti-industry politicians are discussing the case but have so far neither proposed or enacted any legislation that would change the current law. Last week, the woman at the center of this fall’s case was profiled in the New York Times. A guitarist, she lost a hand because a Wyeth medicine was not administered correctly.

A top physician says the usage of electronic medical record (EMR) systems is fraught with problems that are unlikely to benefit medical practice. “EMR vendors aren’t really giving us what we need,” says L. Gordon Moore. “We have to make a distinction between a robust EMR with decision support tools, and one that is just being marketed as a way to improve coding.” Here’s a link.

U.S. and Canadian authorities stopped a central nervous system trial sponsored by Stem Cell Therapeutics. The reason, apparently, is data from a separate trial.

The FDA released another issue of a drug safety newsletter intended to retake some of the high ground claimed by industry critics. The publication’s content is aimed at a scientific audience.  A feature article on medication errors includes a familiar image of a nearly illegible, hand-written prescription. “Of approximately 400 drug name and labels submitted for approval by pharmaceutical companies each year, FDA rejects one-third for reasons of, but not limited to, appropriateness, similar spelling and pronunciation of the drug name to another currently marketed product, ambiguity in a drug name and/or identifier, or being misleading,” the newsletter notes. We’re assuming the entire publication is ghostwritten by people outside the agency, since we could not locate authors for any of the articles. This is the PDF version of the publication.

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