Appeals pathway remains unavailable for challenging regulatory advice on drug and biologic product development programs despite objections from industry; sponsors may approach a higher management level to further discuss such advice in meetings established under the user fee programs, final guidance states.
Drug and biologic product sponsors may request higher level review of US FDA advice on development programs, just not through the agency's formal dispute resolution process.
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The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
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.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
