Industry picks holes in US guidance on expedited drug review programs
This article was originally published in SRA
Executive Summary
A draft guidance document on four expedited review programs available at the US Food and Drug Administration for medicines for serious conditions fails to address adequately a fifth expedited process. In addition, the text omits to mention rare diseases and does not explain how relevant companion diagnostics are to be reviewed in time1-3.
You may also be interested in...
EU Crunch Time For Two Drugs That Lost Their Fast-Track Status
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.
COVID-19: EU Dexamethasone Taw Filing Pulled
The withdrawal of the marketing authorization application for Dexamethasone Taw as a treatment for COVID-19 patients was revealed today in the January meeting agenda of the European Medicines Agency’s human medicines committee, the CHMP.
Kite Strikes CAR-T Access & Discount Deal For Tecartus In England
Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: