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Search Results for 'CBE'

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Published March 25, 2013
Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as… Read More »
Published March 25, 2013
See Changes Being Effected.… Read More »
Published February 27, 2012
See Center for Biologics Evaluation and Research.… Read More »
Published February 27, 2012
The FDA successor to the Bureau of Biologics concerned with biologic drugs and with the new protein and peptide drugs arising from biotechnology. According to its charter, CBER is responsible for ensuring: The safety of the U.S. entire blood suppl… Read More »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »


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