Regulatory & Reimbursement Newsletter

Biocom submitted feedback on the FDA’s Plausible Mechanism Framework; President Trump nominates new CDC director; FDA announces new advancements in clinical trials, and more.

Biocom submitted comments responding to an FDA draft guidance; the FDA announced a leadership change at CBER; the agency launched a new adverse event reporting platform, and more.

Biocom submitted comments on Most-Favored Nation pricing models; the CDC announced a leadership change; the FDA introduced its new plausible mechanism framework, and more.

The FDA announced new regulatory flexibilities for CGT products and the PreCheck pilot to support onshoring, while CDER, the White House, and CMS released major updates on drug approvals, healthcare policy, Medicare price negotiations, supply chain resilience, and more.

Biocom California submitted comments on an FDA draft guidance document, the federal government reopened, the FDA has a new director of its Center for Drug Evaluation and Research (CDER), and more.

Biocom California submitted its comment letter, the FDA announced the first nine recipients of the Commissioner’s National Priority Voucher, publicly released internal filing checklists, and more.

The FDA released its contingency plan and published a trio of cell and gene therapy-related draft guidance documents, finalized a guidance on tools for remotely evaluating drug manufacturing facilities, and more.

Biocom California submitted comments on the reauthorization of the Medical Device User Fee Amendments (MDUFA), FDA released its annual pharmaceutical quality report, and more.

Biocom California provided public comments at the FDA’s meeting on the reauthorization of PDUFA, the FDA announced a new CDER Director, and more.

The Acting Director of CDER is retiring, the FDA unveiled a new priority voucher program, conducted a CEO listening tour across the country, and launched an agency-wide artificial intelligence tool, and more.