For all their bluster about “transparency,” Pam Bondi and Todd Blanche have ignored the requirements of the new law.

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

Last month’s column talked about a simpler way to exchange stackups with manufacturing partners. This month, continuing the ...

President Trump's changing messaging, Congress' unprecedented demands and the Justice Department's piecemeal release of ...