FDA released a draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” to support the use of decentralized clinical trials for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
