PDUFA VI a Must-pass Enhancement And Top Priority For 21st Century Cures
PDUFA VI a must-pass enhancement and top priority for 21st Century Cures
By Mari SerebrovRegulatory Editor
No political tantrums upstaged the importance of passing PDUFA VI in a timely manner when a House subcommittee met Wednesday to discuss the user fee agreement that the FDA, industry and patient groups have negotiated over the past two years.
Rather, members of the Energy and Commerce Health Subcommittee and witnesses reflected on the consequences of not passing the sixth version of the prescription drug agreement by July, positioning PDUFA VI as a top priority and an enhancement to the subcommittee’s 21st Century Cures Act that Congress passed overwhelmingly last year.
If PDUFA isn’t reauthorized on …