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US FDA Performance Tracker Approvals Regulation

Breakthrough Therapy Designations

  • Analysis

Executive Summary

Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.

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Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation

Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.

Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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US FDA Performance Tracker Approvals Regulation
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Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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