Industry representatives did not offer overwhelming support to many of the accelerated approval reforms offered by lawmakers, and their hesitancy suggests it will be more difficult to include the proposed changes in the upcoming user fee legislation.
Accelerated Approval Reform Proposals Worry Industry: ‘Science Doesn’t Move The Same Way’
During House hearing, PhRMA and BIO highlight provisions of PDUFA VII agreement that the associations say would benefit the pathway more than the additional reforms being considered by Congress.
More from Review Pathways
• By
The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
More from Pathways & Standards
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.