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Oncopeptides AB

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Latest From Oncopeptides AB

US FDA Advisory Committees: Flipping FDAAA Mandate On Its Head

FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?

Advisory Committees Politics

Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Clinical Trials ImmunoOncology

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Advisory Committees Post Market Regulation & Studies

From ‘Accelerate’ To ‘Confirm’: US FDA Launches Transparency Program On Cancer Drug Approvals

Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.

Review Pathway Post Market Regulation & Studies
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