The Latest in Regulatory and Reimbursement

Biocom California submitted comments on innovative clinical trial approaches. The FDA authorized a record number of novel medical devices last year and upgraded a CDRH office to a Super Office. The agency announced upcoming plans for Rare Disease Day, released a final guidance on rare disease drug and biological product development, and accepted the first AI-based technology into the FDA’s ISTAND pilot program. CMS sent initial drug price offers to manufacturers last week.

Biocom California Comments on Clinical Trial Approaches

Biocom California submitted responses to the FDA’s request for feedback on Enhancing Adoption of Innovative Clinical Trial Approaches. Thank you to our members for their insights!

FDA Authorized Record Number of Novel Devices

Per the agency’s 2023 Annual Report, the Center for Devices and Radiological Health (CDRH) authorized the highest number of novel devices on record in the Center’s 40-year history.

CDRH Office Elevated to New Super Office

As of January 24, CDRH’s Office of Strategic Partnerships and Technology Innovation (OST) was elevated to a Super Office under the continued leadership of Director Suzanne Schwartz.

Upcoming FDA Rare Disease Day and New Guidance

The FDA released its final guidance on Rare Diseases: Considerations for the Development of Drugs and Biological Products, and will host Rare Disease Day on March 1.

FDA ISTAND Pilot Accepts First AI-Based Technology

FDA’s CDER and CBER accepted the first artificial intelligence-based digital health technology for neuroscience into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

CMS Presents Initial Drug Price Offers

February 1 was the deadline for CMS to send an initial offer of a maximum fair price for a selected drug with a concise justification to each participating drug company in the Medicare Drug Price Negotiation Program.

Upcoming Regulatory and Reimbursement Events: