CMS Off-Label Coverage Decision For Colorectal Cancer Rx Coming Soon
• By The Pink Sheet
The Centers for Medicare & Medicaid Services expects to release proposed national coverage determinations on off-label use of colorectal cancer drugs in the "near future," CMS Chief Medical Officer Sean Tunis, MD, said Sept. 30 at a CMS workshop in Baltimore
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.