Comment Letters

Comment Letters

Biocom California is actively engaged in submitting comments to federal health agencies on draft guidances and proposals. We monitor and engage in important regulatory and reimbursement matters on behalf of the California life science community.

Biocom California Comment Letters

  • Comments on Real-World Evidence for Medical Device Regulatory Submissions – February 20, 2024

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  • Comments on the NIST March-In Framework – February 6, 2024

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  • Comments on Enhancing Adoption of Innovative Clinical Trials Approaches – January 19, 2024

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  • Comments on Quality Consideration for Topical Ophthalmic Drug Products – December 8, 2023

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  • Comments on Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products – November 10, 2023

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  • Comments on Enhanced US Competitiveness Provision – September 12, 2023

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  • Comments on Transitional Coverage for Emerging Technologies – August 11, 2023

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  • Comments on FDA’s Decentralized Trials for Drugs, Biological Products, and Devices – August 1, 2023

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  • Comments on EPA’s Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide – June 27, 2023

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  • Comments on EPA’s Amendments to NESHAP Ethylene Oxide Emissions Standards – June 27, 2023

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  • Comments on the 2023 Farm Bill Reauthorization – June 16, 2023

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  • Comments on the CMS FY 2024 Inpatient Prospective Payment Systems (IPPS) Proposed Rule – June 12, 2023

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  • Comments on Artificial Intelligence in Drug Manufacturing – May 1, 2023

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  • Comments on the Medicare Drug Price Negotiation Program – April 14, 2023

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  • Comments on the IND Application Annual Reporting Proposed Rule – March 8, 2023

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  • Comments on the Joint USPTO-FDA Collaboration Initiatives – February 6, 2023

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  • Comments on the National Biotechnology and Biomanufacturing Initiative – January 20, 2023

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  • Biocom California Comments on FDA’s Rare Disease Endpoint Advancement Pilot Program – December 22, 2022

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  • Biocom California Comments on FDA Draft Guidance on Standards Recognition Program for Regenerative Medicine Therapies – September 14, 2022

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  • Biocom California CMS CY2023 Physician Fee Schedule Proposed Rule Letter – September 6, 2022

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  • Biocom California Risk Management Plans to Mitigate the Potential for Drug Shortages Letter – August 18, 2022

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  • Biocom California Letter to COMPETES/USICA – July 21, 2022

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  • NIH Response to Biocom California to March-In Letter

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  • Biocom California March-In Rights Letter – May 17, 2022

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  • Extension of SBIR/STTR Programs Letter – May 9, 2022

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  • Biocom California FY23 FDA Appropriations Letter – May 4, 2022

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  • Biocom California FY23 Labor & HHS Appropriations Letter – May 4, 2022

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  • Biocom California FY23 MilCon VA Appropriations Letter – May 4, 2022

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  • Biocom California OSTP RFI Response – March 31, 2022

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  • Medical Devices EUA Transition Plan Comment Letter – March 23, 2022

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  • Multi-State MedTech R&D Expensing Letter – March 21, 2022

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  • Multi-State QSBS Letter – March 18, 2022

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  • Biocom California’s Response to the Health Future Task Force’s RFI on Wearable Technologies – March 4, 2022

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  • Comments on National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease – February 11, 2022

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  • Protect the Orphan Drug Tax Credit – February 4, 2022

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  • Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial – December 21, 2021

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  • Medtech Associations Letter Regarding Semiconductor Shortage – November 19, 2021

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  • Comments on Medicare Coverage of Innovative Technology (MCIT) Pathway Removal – October 15, 2021

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  • Comments on FDA Remanufacturing Guidance – September 22, 2021

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  • Comments in Response to PFS FY22 – September 13, 2021

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  • Response to the Cures 2.0 Discussion Draft – July 16, 2021

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