Accelerated approvals

FDA Commissioner: Insurers Need To Support Studies In Accelerated Drug Approval Pathway

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration. Insurers need to help, he said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum.

By Marissa Plescia

Policy

Three important FDA debates flared this week

There's never a dull day at the Food and Drug Administration. This week saw Gottlieb outline some early plans, more commentary on drug pricing, and fresh concern over the agency's 2018 budget.

By Juliet Preston

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.