Avedro Eye Treatment’s Second Rejection Driven By Device, Not Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
Lukewarm support by FDA’s advisors couldn’t get Avedro’s Phoetrexa through agency on its second try, but company seems committed to a third shot at approval.
You may also be interested in...
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
Ivermectin Settlement Brings Relief And Worry For US FDA Communications
The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.
Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses
US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.