FDA FDA Issues Guidance Documents to Streamline Premarket Review and Approval… Thomas Sullivan Apr 2, 2024 0 The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…
CMS CMS Releases Additional Information about the Cell and Gene Therapy (CGT)… Thomas Sullivan Apr 1, 2024 0 The Centers for Medicare and Medicaid Innovation (CMMI) previously released three new payment models, all aimed at lowering drug…