US Generic 'Breakthrough' Pathway Could Have Unintended Consequences
Executive Summary
CDER Director Woodcock warns that incentivizing ANDA development with breakthrough-style approach could have unintended consequences, such as more citizen petitions designed to delay generic availability.
You may also be interested in...
Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
FDA User Fee Bills: Is It Possible For Reauthorization To Be Too Clean?
First draft of user fee omnibus bill is about as 'clean' as a bill can be – free of the policy riders that have always been attached to US FDA funding legislation in past cycles. That is good news for industry, which is eager to see the program reauthorized with as little drama as possible, but could the bill actually be too clean?