Comments on the Use of Monitoring Committees in Clinical Trials – April 15, 2024

Comments on Quality Consideration for Topical Ophthalmic Drug Products – February 26, 2024

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

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

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

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

Comments on Enhanced US Competitiveness Provision – September 12, 2023

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

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

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

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

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

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

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

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

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

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

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

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

Biocom California Comments on FDA Draft Guidance on Standards Recognition Program for Regenerative Medicine Therapies – September 14, 2022

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

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

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

NIH Response to Biocom California to March-In Letter

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

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

Biocom California FY23 FDA Appropriations Letter – May 4, 2022

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

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

Biocom California OSTP RFI Response – March 31, 2022

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

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

Multi-State QSBS Letter – March 18, 2022

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

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

Protect the Orphan Drug Tax Credit – February 4, 2022

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

Medtech Associations Letter Regarding Semiconductor Shortage – November 19, 2021

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

Comments on FDA Remanufacturing Guidance – September 22, 2021

Comments in Response to PFS FY22 – September 13, 2021

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