The Clinical Data Interchange Standards Consortium is conducting a survey of data standards in clinical trials. Respondents should fill out the one-page form by April 19, 2006. Among the questions being asked, one includes the very specific use of eight different formal or draft versions of CDISC standards. The Gartner… more...

The FDA and the Centers for Disease Control have forced Bausch & Lomb to recall its ReNu contact lens solution and a generic version of the same solution. The liquid has been traced to 110 cases of a fungal eye infection that can lead to blindness. “This is a serious… more...

XML4Pharma, a consultancy, has a new CDISC-ODM study designer. For those new to the abbreviations, the Clinical Data Interchange Standards Consortium has an Operational Data Model to standardize certain kinds of clinical trial data. XML4Pharma’s new application spares the clinical user having to learn XML. The software could expedite the… more...

A key FDA whistle-blower has been ordered to testify. Dr. David Graham once publicly estimated that Merck’s painkiller Vioxx had caused 160,000 heart attacks and strokes. The FDA had sought to block Graham’s testimony, but lost that motion in federal court yesterday. Like the big drug company, the FDA is… more...

CDISC, the Clinical Data Interchange Standards Consortium, has a new document about standards for data analysis. The CDISC ADaM Team announced the release of the “Analysis Data Model Version 2.0” document for review and comment. Significant restructuring of the two previously released ADaM models was conducted to produce a single… more...

Sparta Systems of Holmdel, NJ has used its regulatory software to help a division of the Czech drug maker Pliva. Sparta’s TrackWise system is enabling PLIVA to electronically manage quality and regulatory processes. TrackWise is currently deployed at PLIVA’s corporate Brno center of excellence for oncology products. The implementation itself,… more...

Metadata—information about a particular document—was one of the surprises that has come back to haunt Merck in its Vioxx mess. Information that Merck employees thought they had deleted was in fact forwarded to a leading medical journal. Now Microsoft, in a forthcoming release of its operating system, will be taking… more...

A small Cambridge, Mass. company is one of the first to provide solutions for Signatures and Authentication for Everyone (SAFE). SAFE is an industry effort to use software to manage the digital identities of employees. SAFE-BioPharma Association is a global identity management coalition founded by AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson… more...

European regulators will write simple versions of drug safety bulletins. In technical parlance, the EMEA says, summaries of European public assessment reports (EPARs) will be intended for ordinary patients. Each summary will have explanation of how the drug works, what ailments it should be used for, how it was studied,… more...

The FDA has issued a guidance on exploratory investigational new drug (IND) applications.  Such studies are defined as no more than a week long, “The Agency believes that sponsors have not taken full advantage of that flexibility and often provide more supporting information in INDs than is required by regulations.”… more...