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The Latest in Regulatory and Reimbursement
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Biocom California submitted comments on the reauthorization of the Medical Device User Fee Amendments (MDUFA) and responded to a FDA draft guidance. The FDA released its annual pharmaceutical quality report, announced a new program to support onshoring efforts, and began publishing adverse event data on a daily basis. The Department of Health and Human Services (HHS) established a new advisory committee and the Health Resources and Services Administration (HRSA) announced the application process for a new 340B Rebate Model Program.
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Our Comments on Stability Testing and MDUFA
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FDA Pharmaceutical Quality Report Released
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New PreCheck Program Announced
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New HHS Healthcare Advisory Committee Established
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HHS is seeking nominations for committee members to serve on the newly established Healthcare Advisory Committee to advise on programs and policies for US healthcare improvements. |
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HRSA’s New 340B Rebate Model Pilot Program
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The Health Resources and Services Administration (HRSA) announced their application process for the 340B Rebate Model Pilot Program for drugs on the 2026 CMS Medicare Drug Price Negotiation Selected Drug List. They have also issued a request for public comments. |
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FDA Begins Publishing Real-Time Adverse Event Data
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As of August 22, the FDA has begun the daily publishing of data from the FDA Adverse Event Reporting System (FAERS). The FAERS is the primary database for collecting and analyzing adverse event reports, serious medication errors, and quality complaints for drugs and biologics. |
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Request for Comments
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Biocom California welcomes feedback from members on the following topic. Click here to submit comments via email. |
► Onshoring Manufacturing of Drugs and Biological Products; Request for Comments
To facilitate discussion on enhancing domestic pharmaceutical manufacturing, FDA is seeking input on its PreCheck Program proposal, as well as other ideas to incentivize or strengthen pharmaceutical manufacturing in the U.S.
- What do you consider the most significant regulatory hurdle in establishing a new domestic pharmaceutical manufacturing facility?
- Which specific element(s) of the FDA PreCheck proposal are most likely to help the establishment of new US manufacturing facilities?
- Are there additional elements or implementation considerations that should be considered in the FDA PreCheck proposal?
This guidance may be of interest to drug and biological product manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Biocom California
For over 30 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. We connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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