Download Florence Library of FDA eSource and

eRegulatory Guidance

Florence’s library of the GCP inquiries regarding electronic processes. This library contains a complete compilation of the FDA’s published responses to GCP inquiries, from 2002 to 2016, on their webpage. These inquiries stemmed from three main FDA guidance documents:

Inside this library are the FDA’s responses to computer questions and our summaries of those exchanges. Each question, with its subsequent summary, is linked to the table of contents, so you can simply click a question and access its summary. Following each summary is the full account released by the FDA, for additional understanding of the agency’s guidance.

Download Florence Library of FDA Responses

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