ARM is the sector’s lead advocate for clear, predictable, and harmonized regulatory and review pathways for regenerative medicine and advanced therapy products in the U.S. and Europe.
Clear and predictable approval process regulation ensures product developers are able to understand the data and other requirements needed for approval and navigate the regulatory process without unnecessary delays or uncertainty.
And internationally harmonized regulation—the creation of globally consistent regulatory policies—facilitates the rapid and efficient development and introduction of regenerative medicine products across multiple markets worldwide, to the benefit of both manufacturers and patients.
Review existing scientific standards and initiatives to identify key regulatory issues and to provide information and support to product developers and regulatory agencies.
Advocate for improved communication between product developers and regulatory bodies throughout the development pipeline.
Present at public meetings held by regulatory bodies to discuss best practices for translating scientific discoveries into innovative products for patients.
Submit comments on the implications of proposed regulations for the regenerative medicine sector.
Work with legislators and other policymakers to maintain and modify as appropriate the regulatory framework for regenerative medicine and advanced therapies.
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (the “Proposed Rule”).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Ensuring Access to Medicaid Services (the “Proposed Rule”).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed payment updates to the fiscal year 2024 Hospital Inpatient Prospective Payment System (Proposed Rule).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed payment updates to the calendar year 2023 Medicare Physician Fee Schedule (Proposed Rule).
The Alliance for Regenerative Medicine (ARM) greatly appreciates that CMS hosted a Discarded Drug Refund Policy Town Hall, and we look forward to working with CMS to develop policies and processes that create transparency and predictability for manufacturers.
In comments submitted to the European Commission, ARM highlights the potential for the European Health Data Space (EHDS) to advance patient access to cell and gene therapies.