Biocom 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. Members are notified of draft guidances and proposals that are open for consideration by email and in our Regulatory Affairs Communique (RAC) Newsletter.
We also encourage members to contact us if there is an issue they would like us to engage in. Our positions are thoroughly vetted by our Regulatory Affairs, Federal, and Board-level policy committees before submission.
Biocom Comment Letters
- 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
- Biocom MCIT Pathway Comment Letter Final – April 16, 2021
- MFN IFR Comments – January 26, 2021
- Medicare Coverage of Innovative Technology (MCIT) – November 2, 2020
- 2021 PFS Proposed Rule – October 5, 2020
- Multistate Comment Letter on CMS VBP Proposed Rule Final – July 20, 2020
- FDA Interpreting Gene Therapy Sameness – July 20, 2020
- CMS 2021 IPPS Proposed Rule – July 10, 2020
- FDA Importation of Prescription Drugs – Mar 9, 2020
- FDA Bridging for Combo Products – Feb 18, 2020
- FDA Requesting Feedback on Combo Products – Feb 18, 2020
- CMS 2020 PFS Proposed Rule – Sep 27, 2019
- CMS 2020 IPPS Proposed Rule – June 21, 2019
- ONC Data Blocking Rule – June 3, 2019
- FDA AI Discussion Paper – June 3 2019
- CMS DTC Ad Rule – Dec 17, 2018
- FDA Long Term Follow-Up Gene Therapy – Dec 10, 2018
- HHS RFI Blueprint to Lower Drug Prices – Aug 27, 2018
- NIH Strategic Plan for Data Science April 2, 2018
- FDA Expedited Programs for Regenerative Medicine – Feb 15, 2018
- FDA Evaluation of Devices Used with Regenerative Medicine – Feb 15, 2018
- CMS Protecting Access to Medicine CLFS Rates – Oct 23, 2017
Additional Resources
