Comment Letter Library

drugs-biologics-letters

Drugs & Biologics Regulation

Quality Consideration for Topical Ophthalmic Drug Products

February 26, 2024

Letter to FDA

Enhancing Adoption of Innovative Clinical Trials Approaches

January 19, 2024

Letter to FDA

Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

November 10, 2023

Letter to FDA

Artificial Intelligence in Drug Manufacturing

May 1, 2023

Letter to FDA

IND Application Annual Reporting Proposed Rule

March 8, 2023

Letter to FDA

December 22, 2022

Letter to FDA

September 14, 2022

Letter to FDA

August 18, 2022

Letter to FDA

February 4, 2022

Letter to Congress

December 21, 2021

Letter to FDA

medical-device-letters

Medical Device Regulation

Real-World Evidence for Medical Device Regulatory Submissions

February 20, 2024

Letter to FDA

Transitional Coverage for Emerging Technologies

August 11, 2023

Letter to FDA

Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide

June 27, 2023

Letter to EPA

Amendments to NESHAP Ethylene Oxide Emission Standards

June 27, 2023

Letter to EPA

RFI on Digital Health Technologies Response

March 31, 2022

Letter to OSTP

March 23, 2022

Letter to FDA

March 4, 2022

Letter to Congress

September 22, 2022

Letter to FDA

general-regulation-letters

General Regulation

Key Information and Facilitating Understanding in Informed Consent

April 29, 2024

Letter to FDA

The Use of Monitoring Committees in Clinical Trials

April 15, 2024

Letter to FDA

FDA's Decentralized Trials for Drugs, Biological Products and Devices

August 1, 2023

Letter to FDA

Response to the Cures 2.0 Discussion Draft

July 16, 2021

Letter to Congress

reimbursement-letters

Reimbursement

July 2, 2024

Letter to CMS

June 7, 2024

Letter to MACs

FY 2024 Inpatient Prospective Payment Systems (IPPS) Proposed Rule

June 12, 2023

Letter to CMS

Medicare Drug Price Negotiation Program

April 14, 2023

Letter to CMS

2023 Physician Fee Schedule Proposed Rule

September 6, 2022

Letter to CMS

National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

February 11, 2022

Letter to CMS

Response to Physician Fee Schedule

September 13, 2021

Letter to CMS

tax-letters

Taxes & Funding Programs

2023 Farm Bill Reauthorization

June 16, 2023

Letter to Congress

Multi-State MedTech Ru0026D Expensing Letter

March 21, 2022

Letter to Congress

Multi-State QSBS Letter

March 18, 2022

Letter to Congress

Letter to COMPETES/USICA Conferees to Include SBIR/STTR Extension

July 21, 2022

Letter to Congress

Supporting the Extension of SBIR/STTR Programs

May 9, 2022

Letter to Congress

intellectual-property-letters

Intellectual Property

July 10, 2024

Letter to USPTO

June 3, 2024

Letter to USPTO

National Institute of Standards u0026 Technology March-In Framework

February 6, 2024

Letter to NIST

Joint Agency Collaboration Initiatives on Patents

February 6, 2023

Letter to USPTO/FDA

NIH Response to Biocom California's March-In Letter

June 2, 2022

Letter to NIH

Opposing March-In Rights

May 17, 2022

Letter to NIH

manufacturing-letters

Manufacturing & Supply Chain

Enhanced U.S. Competitiveness Provision in Government Contracts

September 12, 2023

Letter to DOE

The National Biotechnology and Biomanufacturing Initiative

January 20, 2023

Letter to OSTP

appropriations-letters

Appropriations

FY 2025 Appropriations

May 2024

Letter to Congress

April 29, 2024

Letter to Ag/FDA

April 29, 2024

Letter to Labor/Health

March 30, 2023

Letter to MilCon/VA

March 23, 2023

Letter to Ag/FDA

March 23, 2023

Letter to Labor/Health

Biocom California Comment Letters

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

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  • 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 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 u0026 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 Ru0026D 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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