CBER outlines future biologics, biosimilars plans

With greater development of biologic medications, biosimilars and companion diagnostics, the FDA Center for Biologics Evaluation and Research's role in health care is growing, speakers said at FDLI's annual meeting. CBER office directors discussed plans for the center, which include a push to publish the draft guidance Preclinical Safety Assessment of Investigational Cellular and Gene Therapy Products.

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CBER Importance Boosted With Attention To Biologic Drugs, Biosimilars, Speakers Say - Bloomberg BNA

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