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FDA Reviewers Share CMC, GMP Challenges In Last Year's Rush To Approve New Therapies

 
• By Bowman Cox

Inundated with high-priority applications last year, US FDA's CMC reviewers struggled with seemingly thrown-together review packages, moving-target manufacturing processes and not-on-the-same-page contract manufacturers.

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Several FDA review officials shared their frustrations with last year's exhilarating but challenging rush to market for highly anticipated biotechnology, biosimilar, vaccine, cell and gene therapies.

A panel of chemistry, manufacturing and controls experts told a rapt audience Jan

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