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ARM CEO Janet Lambert sent a letter to CBER Director Peter Marks in response to FDA Commissioner Gottlieb’s announcement that the agency will be developing disease-specific guidances for gene therapy, the first of which covers hemophilia treatments.
ARM’s Science & Technology and Regulatory Committees’ joint task force submitted comments to the FDA on its recent CMC and Standards guidance.
ARM submits comments in response to “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies” draft guidance.
ARM submits comments in response to “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions” draft guidance.
ARM submits comments in response to the Office of Inspector General’s request regarding the OIG’s “safe harbors,” activities that are deemed in advance to not violate the Anti-Kickback Statute and other laws. These provisions can complicate or limit pay-for-performance arrangements with CMS.
ARM Co-Founder & Senior Policy Counsel Michael Werner delivered comments at the CMS public meeting.
Comments
ARM has submitted comments on the EMA’s “Guideline on Safety and Efficacy Follow-Up and Risk Management of Advanced Therapy Medicinal Products.” In addition to various requests for clarification throughout the guidance, ARM also suggested the creation of a separate document for pre-authorization safety expectations, or to clarify whether the recommendations apply to all ATMPs or only to specific ATMP types