Regulatory & Reimbursement Newsletter

The FDA launched the Neuroscience Advancement Innovation Nexus program, CMS issued a proposed rule implementing the Consolidated Appropriations Act, 2026 on Medicare Advantage, California received more than $233 million in Rural Health Transformation Program funding and more.

Biocom commented on PDUFA VIII Commitments, CMS finalized its GLOBE Model, the FDA launched the expedited Investigational New Drug pilot program and more

The FDA hosted a public meeting to discuss the PDUFA VIII draft commitment letter, Dr. Heidi Overton has been nominated as the new FDA commissioner, CMS released details of the new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway and more.

Dr. Erica Schwartz’s nomination to serve as CDC director has advanced to the full Senate for consideration, CMS recently issued the CY 2027 Medicare Physician Fee Schedule proposed rule, FDA has finalized negotiations on the draft MDUFA VI commitment letter and more.

 Chris Klomp has been nominated by President Trump to serve as HHS Deputy Secretary, FDA is requesting input on a proposed pilot program designed to shorten the time from drug identification to first-in-human Phase 1 clinical trials, CBER’s Office of Therapeutic Products’ acting director has stepped down and more.

Biocom submitted comments in response to the FDA’s draft guidance on the use of new approach methodologies in drug development; Kyle Diamantas will serve as acting FDA commissioner following Dr. Makary’s resignation; Michael Davis has been appointed acting director of CDER and more.

Biocom submitted feedback on the FDA’s Plausible Mechanism Framework; President Trump nominates new CDC director; FDA announces new advancements in clinical trials, and more.

Biocom submitted comments responding to an FDA draft guidance; the FDA announced a leadership change at CBER; the agency launched a new adverse event reporting platform, and more.

Biocom submitted comments on Most-Favored Nation pricing models; the CDC announced a leadership change; the FDA introduced its new plausible mechanism framework, and more.

The FDA announced new regulatory flexibilities for CGT products and the PreCheck pilot to support onshoring, while CDER, the White House, and CMS released major updates on drug approvals, healthcare policy, Medicare price negotiations, supply chain resilience, and more.