Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.

Wallach, Joshua D; Luxkaranayagam, Anita T; Dhruva, Sanket S; Miller, Jennifer E; Ross, Joseph S

Wallach, Joshua D; Luxkaranayagam, Anita T; Dhruva, Sanket S; Miller, Jennifer E; Ross, Joseph S.

Affiliation

Wallach JD; Department of Environmental Health Sciences, Yale School of Public Health, 60 College Street, 4th Floor, Room 411, New Haven, CT, 06510, USA. Joshua.wallach@yale.edu.
Luxkaranayagam AT; Collaboration for Research Integrity and Transparency (CRIT), Yale Law School, 157 Church Street, 17th Floor, Suite 1, New Haven, CT, 06510, USA. Joshua.wallach@yale.edu.
Dhruva SS; Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, 1 Church Street, Suite 200, New Haven, CT, 06510, USA. Joshua.wallach@yale.edu.
Miller JE; Collaboration for Research Integrity and Transparency (CRIT), Yale Law School, 157 Church Street, 17th Floor, Suite 1, New Haven, CT, 06510, USA.
Ross JS; University of Connecticut, Storrs, CT, 06269, USA.

BMC Med ; 17(1): 117, 2019 06 17.

Article in En | MEDLINE | ID: mdl-31203816

Subject(s)
Key words

FDA; Lifecycle evaluation; Pharmaceutical regulation; Postmarketing commitments; Postmarketing requirements

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Drug Approval Type of study: Observational_studies / Prevalence_studies / Risk_factors_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: BMC Med Journal subject: MEDICINA Year: 2019 Document type: Article Affiliation country: Estados Unidos Country of publication: Reino Unido

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