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The Latest in Regulatory and Reimbursement
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Biocom California summarized the CMS Drug Price Negotiation Program revised guidance as implementation deadlines begin for manufacturers. FDA published an updated draft guidance on formal meetings for PDUFA products and the agency formalized the ASCA pilot program. CDRH developed an international harmonization strategic plan, and the deadline for an orphan product funding opportunity is approaching.
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Our Digest of the Negotiation Program Guidance
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IRA Drug Price Negotiation Program Deadlines Looming
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Manufacturers of selected Part D drugs were required to enter into a Negotiation Program Agreement with CMS by October 1 and their data submissions are due to the agency by today, October 2.
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FDA Issues CDRH International Harmonization Plan
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Funding Opportunity for Orphan Products Grant Program
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Updated Draft Guidance for FDA Meetings
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FDA’s ASCA Program to Become Permanent
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Request for Comments
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Biocom California welcomes feedback from members on the following FDA draft guidance document. Click here to submit comments by Friday, October 13. |
- Product stability and delivery device compatibility as a result of manufacturing changes.
- CMC changes requiring a new IND submission and reporting changes to an IND and BLA.
- Special considerations for tissue-engineered medical products.
This guidance may be of interest to sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products.
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Upcoming Regulatory and Reimbursement Events:
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Biocom California
For over 28 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over {{{dynamic_content_1600}}} companies, 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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