Roche's QRM program forged in crisis after Viracept recalled from AIDS epidemic in Africa due to GMP snafu. Upper management promised EU regulators a global review, called QuaSar. Massive effort involved training thousands of workers on how to assess risks and performing 100,000 FMEA risk assessments in just the first year. How Roche addressed the risks identified, replacing machines and even whole facilities when deemed necessary. How Roche transitioned to the proactive post-crisis second phase of its QRM program. The problem with doing FMEAs on Excel spreadsheets.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
