Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration.
cross_sectional · Level IV
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- Record sourced from PubMed, PMID 31157824.
- Also identified by DOI 10.1001/jamainternmed.2019.1213 and PMC identifier 6547098.
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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.