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FDA Blog

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Time is of the Essence: Regulatory Administrative Action Letters

By Christina Sanchez Miller, MPH

  06/16/2019

  Category: Regulatory

Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps) establishments are regulated under FDA’s Center of Biologics Evaluation & Research (CBER). HCT/Ps...

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biologics consulting group

I Received an FDA Regulatory Advisory Action Letter, Now What?

By Christina Sanchez Miller, MPH

  06/11/2019

  Category: Regulatory

The biologics industry is heavily regulated with FDA’s ever-changing landscape of regulatory components. The FDA has an objective to ensure biologics companies...

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