ARTICLE SUMMARY:
The recently-proposed RAPID pathway to align regulatory approval and Medicare coverage is getting a mixed reception from industry and reimbursement experts. Similarly, the jury is still out on new EU-wide Joint Clinical Assessments to streamline European market access. The MDUFA VI draft aims to mostly maintain the status quo; CMS offers a two-year grace period for NTAPs; and we unveil our new and improved Document Depot global policy database.
