Jen Lamppa, VP of Commercial Strategy at Inovalon, says that RWD will be held to the same scrutiny as trial data if used in ...

The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025.

With the 2024 election in the rearview mirror and the dust settling nationally and here in the state, we must make clear that in Colorado we believe in good governance and take fulfilling our ...

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to ...

By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most ...

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...

In an opinion piece published in the Wall Street Journal this week, US President Barack Obama wrote that the US Food and Drug Administration (FDA) is set for reform: "Tomorrow the FDA will lay out a ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...