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Research Letter
June 3, 2019

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

Author Affiliations
  • 1Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland
  • 2Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, New Brunswick
  • 3Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
  • 4Center for Science in the Public Interest, Washington, DC
JAMA Intern Med. Published online June 3, 2019. doi:10.1001/jamainternmed.2019.1213

Current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing the existence of pending New Drug Applications (NDAs) or Biologics License Applications (BLAs) unless previously publicly disclosed or acknowledged.1 Applicants may disclose applications in press releases, Securities and Exchange Commission (SEC) filings, or in other media; how frequently they do so is not known.

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