FDA user fees

House Energy and Commerce Committee passes bill outlining FDA procedures to withdraw a drug

To withdraw a drug from the market, the FDA will have to provide the drug sponsor with notice and an explanation as well as the opportunity to meet with the FDA, addressing increased scrutiny on the FDA's accelerated approvals program.

By Amanda James

Pharma, Policy

FDA raises its PDUFA and MDUFA user fees

As it does every year, the FDA has changed its PDUFA and MDUFA fees - and in most cases, it increases.

By Meghana Keshavan

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.