Biocom California has responded to the White House’s recent Request for Information on the biotechnology and biomanufacturing initiative. The FDA has released a report highlighting last year’s novel drug approvals, CDER and CBER are resuming some in-person face-to-face meetings, and a final rule has been published with updates to radiological health regulations. CMS has announced key dates for the first year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act and the agency has engaged stakeholders to provide more feedback on its Discarded Drug Refund Policy.
With its Broad Agency Announcement Day near, the FDA has published initiatives for advancing regulatory science research and development. The agency’s Cybersecurity Modernization Action Plan has been released, and in a recent report the FDA highlighted its successful use of computational modeling and simulation for regulatory decision making.