FDA plasmid DNA vaccines points to consider to be published in November.
FDA PLASMID DNA VACCINES POINTS TO CONSIDER TO BE PUBLISHED IN NOVEMBER Federal Register for comment, FDA Senior Regulatory Reviewer Herbert Smith, PhD, told the Vaccines & Related Biological Products Advisory Committee Oct. 30. The purpose of the document is to "provide manufacturers with preliminary guidance regarding the manufacture and preclinical evaluation of plasmid DNA vaccines intended for clinical studies in preventive infectious disease indications and to assist manufacturers in the preparation of INDs for use of these vaccines," the draft document states.
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