CBER

Sequester cuts could snarl approvals for years

Sequester cuts could snarl approvals for years

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With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.

Dendreon draws CBER letter for Provenge professional marketing

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The Center for Biologics Evaluation and Research hit Dendreon with an untitled letter for false and misleading professional marketing materials for its prostate cancer treatment Provenge.

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