The FDA’s efforts are meant to reduce phase 1 timelines by six to 12 months, Diamantas said. They include what he called an “expedited” investigational new drug pilot program, updated guidance on the use of advanced computer models for dose selection and updated frameworks for clinical trial master protocols.

Tariff Recovery Group is expanding capacity to get businesses filed for IEEPA refunds correctly before CAPE Phase 1’s rolling deadline

Fred Hutchinson Cancer Center leads the way when it comes to offering eligible patients alternative options when conventional therapies no longer work. With more than two dozen phase 1 clinical trials active at any given time, Fred Hutch is constantly ...