FDA's Compassionate Use Initiatives: Web Clearinghouse, Guidance Documents
This article was originally published in The Pink Sheet Daily
Expanded Access Navigator offering directory of manufacturers' procedures and points of contact will depend upon industry cooperation, stakeholders at Reagan-Udall Foundation meeting conclude.
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New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.
Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.