Login to Your Account



Regulatory NEWS

FDA experts are teaming up with patients to help drug developers explore one of the final frontiers in the human body as they seek new cures and therapies for neurological diseases.

Consider it the fulfillment of President Donald Trump's campaign promise to bring down drug prices in the U.S. That's how White House Budget Director Mick Mulvaney framed the administration's proposal to give the FDA a hefty spending hike in fiscal 2019 through user fees and tax dollars.

Nearly 35 years after Hatch-Waxman cleared the way for a robust generics industry, the U.S. is still waiting for lightning to strike twice, this time with biosimilars.

More Regulatory Headlines

Cast Your Vote

Should there be restrictions on the use of gene-editing technology?: