Comment Letters

Comment Letters

Biocom California is actively engaged in submitting comments to federal agencies and Congress on draft guidances and proposals. We monitor and engage in important legislative, regulatory and reimbursement matters on behalf of the California life science community. Click a topic on the right to review submitted letters.

drugs-biologics-letters

Drugs & Biologics Regulation

August 8, 2024

Letter to FDA

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

medical-device-letters

Medical Device Regulation

Real-World Evidence for Medical Device Regulatory Submissions

February 20, 2024

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

general-regulation-letters

General Regulation

September 25, 2024

Letter to FDA

August 2, 2024

Letter to Congress

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

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 9, 2023

Letter to CMS

August 11, 2023

Letter to CMS

tax-letters

Taxes & Funding Programs

2023 Farm Bill Reauthorization

June 16, 2023

Letter to Congress

Multi-State MedTech R&D 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

intellectual-property-letters

Intellectual Property

July 10, 2024

Letter to USPTO

Setting and Adjusting Patent Fees During Fiscal Year 2025

June 3, 2024

Letter to USPTO

National Institute of Standards & Technology March-In Framework

February 6, 2024

Letter to NIST

Joint Agency Collaboration Initiatives on Patents

February 6, 2023

Letter to USPTO/FDA

manufacturing-letters

Manufacturing & Supply Chain

Enhanced U.S. Competitiveness Provision in Government Contracts

September 12, 2023

Letter to GAO

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