Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020.

Moneer, Osman; Lee, ChangWon C; Avorn, Jerry; Kesselheim, Aaron S

Moneer, Osman; Lee, ChangWon C; Avorn, Jerry; Kesselheim, Aaron S.

Moneer O; Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Lee CC; Yale School of Medicine, Yale University, New Haven, Connecticut.
Avorn J; Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Kesselheim AS; Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

JAMA Netw Open ; 4(4): e218530, 2021 04 01.

Article in English | MEDLINE | ID: covidwho-1298440

Subject(s)

Drug Approval; Product Surveillance, Postmarketing; Research; Social Control, Formal; United States Food and Drug Administration; Vaccines; Cross-Sectional Studies; Drug Industry/legislation & jurisprudence; Drug Monitoring; Humans; Research/legislation & jurisprudence; United States

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Product Surveillance, Postmarketing / Research / Social Control, Formal / United States Food and Drug Administration / Vaccines / Drug Approval Type of study: Observational study / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2021 Document Type: Article

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