Amsel Medical Corporation

The US Food and Drug Administration looks well-prepared to work with Congress over the next two years to reauthorize its core user fee programs. Incoming FDA Commissioner Martin Makary, whose nominati

Real-world evidence once again will be among the themes of a congressional effort to streamline and improve access to biomedical innovation. US Reps. Diana DeGette, D-CO, and Fred Upton, R-MI, are loo

The US Food and Drug Administration is willing to grant regulatory flexibility for manufacturers of cell and gene therapy products from certain chemistry, manufacturing and controls (CMC) requirements

As the US Food and Drug Administration and industry cannonballed into June with an explosion of drug development announcements, it was impossible to keep the news brief. So we'll skip the preamble thi