Michael McCaughan
Latest From Michael McCaughan
Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur
Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.
The Long And Short Of Accelerated Approval Accountability In US
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
As US House Changes Hands, CMS May Face More Oversight Than FDA
Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.
Status Quo Senate Still Means Big Changes For FDA Oversight
The mid-term elections left the US Senate under Democratic leadership – but there are still big changes coming that may make life tougher on FDA and the brand name industry.
US Medicare Wastage ‘Refund’ Collections Delayed To ‘Align’ With IRA
A new Medicare rebate for discarded portions of single-use vials is taking effect as scheduled in January – but the first invoices won’t be issued in the fall as planned. CMS says it wants to wait to ‘align’ the collections process with the new inflation rebates enacted by the IRA.
US FDA Ready To Move Forward On Developing Quality Management Maturity Rating System
The US FDA will begin work on operationalizing a Quality Management Maturity rating system following a public vote of confidence from its outside advisory committee. There are plenty of key details still to be worked out.