Before a therapy is approved for delivery to patients a lot of hard work and research goes into demonstrating that the therapy is safe, effective, and high quality. We work to promote a regulatory environment that supports safe and efficient development and approval of therapies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
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BIO White Paper on FDA’s Statement of Patient Experience
In September 2017, FDA implemented the Patient Experience Data table (PED Table) to be completed by reviewers and included in NDA/BLA review documents...
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