ArticleThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2023
Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform.
Article in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Factors influencing FDA drug approval decisions beyond clinical trial evidence: a scoping review.Health affairs scholar · 2026Review
- Improving Consumer Engagement in Health Technology Assessment and Decision Making: Lessons from 'Values in Science'.Applied health economics and health policy · 2026Review
- Great Trees Require Strong Roots: Evaluating Data and Delegation Doctrine Underlying Proposed Reforms to FDA's Accelerated Approval Program.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
Corrections and comments
- Commented on by
Authors and funding
1 author at 1 institution in 1 country.
Funding
Abstract
The US Food and Drug Administration's controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer's disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA's core priorities and restore the regulatory system's commitment to scientific rigor.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.