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Laura Helbling
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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.