Chimerix And FDA’s Compassionate-Use Solution
This article was originally published in The Pink Sheet Daily
A media storm is over and Chimerix has resumed focus on the Phase III trial of its lead program, thanks to quick work by the company and FDA to design a trial providing access to brincidofovir in immunocompromised patients with adenovirus.
You may also be interested in...
FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors
New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.
'Right To Try' And PDUFA VI: Patient Advocates, Industry Fight Senate Add-On
Given that 'right to try' is intended to be a patient-centered proposal, patient organizations are a strong voice in opposition, working behind the scenes to revise – or entirely exclude – the legislation as part of the user fee package. But the bill also has powerful advocates among Senate Republicans and in the Trump Administration.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.