The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in...more
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more