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Laura Helbling
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Latest From Laura Helbling
Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies'
Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.
Gene Therapy In The Real World: Long-Term Follow Up Is Key – If Patients Are Willing
The first of what promises to be a wave of potentially curative gene therapies are coming to market. One of the challenges for sponsors will be how to deliver long-term outcomes data demanded by regulators and payors from patients who don’t have any reason to go to the doctor.
US FDA’s Record Tally Of NMEs Outpaces Ability To Issue Press Releases
US FDA’s Most Unusual Advisory Committee
“One Continuous Trial” In Oncology: US FDA Offers Guidance And Encouragement
One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.