Regulatory Affairs

FDA Issues Guidances on Gene/Cellular Therapies

The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More

Drugmakers to Pay Louisiana $88 Million in Fraud Settlement

Twenty-five drugmakers, including generic drugmakers Ranbaxy and Perrigo, have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More