The Latest in Regulatory and Reimbursement

Biocom California submitted its comment letter responding to the Department of Commerce’s Section 232 investigations on the national security effects of imports of personal protective equipment and medical devices. The FDA announced the first nine recipients of the Commissioner’s National Priority Voucher, publicly released internal filing checklists, and published a new draft guidance reforming biosimilar regulatory recommendations. CMS temporarily recalled furloughed staff to support open enrollment for Medicare and Affordable Care Act plans and published its final guidance for the Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2028.

Biocom Comments on Recent Section 232 Investigation

Biocom submitted a comment letter responding to the Section 232 investigations on the national security effects of imports of personal protective equipment and medical devices.

FDA Announces First Recipients of CNPV

The FDA announced the first nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program and more recipients will be announced in the coming months.

FDA Biosimilar Reforms Underway

The FDA is reforming aspects of its regulatory approach for biosimilars. The agency released a new draft guidance which would reduce the need for comparative studies and it plans to finalize a separate guidance regarding interchangeability and switching studies. 

FDA Releases Filing Checklists

The FDA publicly released application filing checklists used internally by CDER staff to determine if a submitted application is complete and reviewable. This is part of an agency effort to increase transparency into FDA filing procedures. 

CMS Publishes Final MDPNP Guidance for IPAY 2028

CMS released the Medicare Drug Price Negotiation Program (MDPNP)  Final Guidance for Initial Price Applicability Year (IPAY) 2028, outlining the process for the third cycle of negotiations.

Furloughed CMS Staff Return to Support Open Enrollment

Despite the ongoing government shutdown, furloughed CMS staff will temporarily return to the agency to support open enrollment for Medicare and Affordable Care Act plans.

Upcoming Regulatory and Reimbursement Events:

Featured Members

Congratulations to Biocom California member, Bayer, on the FDA approval of its drug, Lynkuet, for the treatment of moderate to severe hot flashes due to menopause.