|
|
|
The Latest in Regulatory and Reimbursement
|
|
Biocom submitted feedback on the FDA’s proposed Expedited Investigational New Drug pilot program. The White House released its Unified Agenda. The Senate held a confirmation hearing and voted to advance Dr. Erica Schwartz’s nomination for CDC director the full Senate for consideration. CMS issued its CY 2027 Physician Fee Schedule proposed rule and released a new draft guidance on processes related to the Medicare Drug Price Negotiation Program. FDA published the draft commitment letter for the medical device user fee program for fiscal years 2028 through 2032.
|
|
|
|
|
|
Biocom Comments on FDA Proposed Pilot Program
|
Biocom submitted feedback on the FDA’s proposed Expedited Investigational New Drug pilot program which is intended to shorten the time from drug identification to first-in-human study. |
|
|
|
New Unified Agenda Outlines FDA Policy Plans
|
FDA is slated to issue 22 final and 43 proposed rules this year, including new policies related to the disclosure of complete response letters, direct-to-consumer drug advertisements, clinical trial reform and more. |
|
|
|
|
Senate Committee Advances CDC Director Nomination
|
Dr. Erica Schwartz, nominated to serve as CDC Director, appeared before the Senate for her confirmation hearing. Following the hearing, the committee voted to advance her nomination to the full Senate for consideration. |
|
|
|
CY 2027 Physician Fee Schedule Proposed Rule
|
|
|
|
|
|
|
CMS Releases Medicare Drug Price Negotiation Program Draft Guidance
|
CMS recently issued a draft guidance detailing the processes and requirements for manufacturer effectuation of the maximum fair price in 2028 under the Medicare Drug Price Negotiation Program. |
|
|
|
Medical Device User Fee Amendments (MDUFA VI) Reauthorization Underway
|
FDA and industry have finalized negotiations on the draft MDUFA VI commitment letter, which outlines program goals for 2028–2032. The final agreement will be transmitted to Congress for the program’s reauthorization. |
|
|
|
|
Request for Comments
|
Biocom welcomes feedback from members on the following FDA draft guidance. Click here to submit comments via email. |
|
|
|
|
|
|
|
Upcoming Regulatory and Reimbursement Events:
|
|
|
|
Featured Members
Congratulations to Dexcom for being the first manufacturer selected to participate in the FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot program.
|
|
Biocom Policy & Advocacy
Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.
|
|
|
