FDA REMS “Platform” Model Unveiled At Public Meeting; Pilot Test Using Structured Product Labeling Is First Step
This article was originally published in RPM Report
You may also be interested in...
FDAAA Impact Analysis (Year 7): The Era of the “Breakthrough” REMS
FDA continues to use the formal Risk Evaluation & Mitigation Strategy authority very infrequently in the context of new drug approvals. There is one countervailing trend: the agency is imposing mandatory communication plans for some of the new oncology therapies – including two “Breakthroughs.”
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign
President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.