In Brief: Medstone International
This article was originally published in The Gray Sheet
Executive Summary
Medstone International: Agrees to an out-of-court settlement of the shareholders' lawsuit initiated against it and certain officers and directors in October 1989. The settlement agreement calls for the lithotripsy firm to pay $5.5 mil. in cash of a total $6 mil. settlement. The settlement "is not an admission of any liability," Medstone says. The suit alleged that the firm withheld adverse material information at the time of its initial public offering in June 1988...
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.