FDA To Follow EMEA's Lead: ODAC Votes To Require Randomized Controlled Trials For Future Cutaneous T-Cell Lymphoma Drug Approval
Executive Summary
FDA may soon follow the European Medicine Agency's lead in approval standards for cutaneous T-cell lymphoma drugs by requiring randomized clinical trials for future drug development
You may also be interested in...
Buoyed by Positive Trial Data, Private Yaupon Prepares To File Topical Chemo For Early CTCL
FDA orphan R&D grant and academic ties start to pay off for biotech's lead drug, a topical gel of a generic chemotherapy aimed at 20,000 patients with early-stage skin cancer.
Post-Market Trials Could Broaden Label For Allos' Newly Approved Folotyn
Two of the four post-market studies Allos is required to conduct as part of Folotyn's Sept. 24 accelerated approval could broaden the label of the oncologic, newly cleared for treatment of relapsed or refractory peripheral T-cell lymphoma
Post-Market Trials Could Broaden Label For Allos' Newly Approved Folotyn
Two of the four post-market studies Allos is required to conduct as part of Folotyn's Sept. 24 accelerated approval could broaden the label of the oncologic, newly cleared for treatment of relapsed or refractory peripheral T-cell lymphoma