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Manufacturers › Center for Biologics Evaluation and Research (CBER) › Biologics

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

Morgan Lewis - As Prescribed on

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

King & Spalding

FDA’s Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes

King & Spalding on

Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more

Hogan Lovells

FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience - Long-Awaited ICH Q13 draft...

Hogan Lovells on

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more

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