Laura Helbling
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Laura Helbling
New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest
CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.
Mandatory Efficacy Trials: US FDA Affirms Broad Scope Of New Post-Market Authority
Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.
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.