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

Harinder Singh Chahal; David Szeto; Anam H Chaudhry; Daniel W Sigelman; Stella Kim; Peter G Lurie

doi:10.1001/jamainternmed.2019.1213

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

JAMA Intern Med. 2019 Aug 1;179(8):1144-1146. doi: 10.1001/jamainternmed.2019.1213.

Authors

Harinder Singh Chahal¹, David Szeto², Anam H Chaudhry¹, Daniel W Sigelman¹, Stella Kim³, Peter G Lurie⁴

Affiliations

¹ Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
² Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, New Brunswick.
³ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
⁴ Center for Science in the Public Interest, Washington, DC.

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.