Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration.

Chahal, Harinder Singh; Szeto, David; Chaudhry, Anam H; Sigelman, Daniel W; Kim, Stella; Lurie, Peter G · JAMA Intern Med · 2019

cross_sectional · Level IV

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Abstract

This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants disclose applications in the media.