1. Pink Sheet

US FDA Pursuing Two-Track Approach To Regulatory Convergence For Cell and Gene Therapies

 
• By Nielsen Hobbs

Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.

HOME-TOWN HERO RICHARD PAZDUR WAS ONLY REGULATOR ON STAGE DURING THE FDA TOWN HALL THAT Concluded THE DIA ANNUAL MEETING IN CHICAGO. • Source: Nielsen Hobbs

The US Food and Drug Administration is pursing a two-track approach to advance global regulatory converge for cell and gene therapies, Center for Biologics Evaluation and Research director Peter Marks told the closing session of the Drug Information Association annual meeting on 23 June.

“We’re not going directly for harmonization, we’re trying for some regulatory convergence first,” Marks said, meaning that a sponsor could still face different requirements in

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