Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

ABSTRACT: OBJECTIVES:To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency. DESIGN AND SETTING:Cross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010. Regulatory documents from both agencies were used. PRIMARY AND SECONDARY OUTCOME MEASURES:All identified postmarketing studies were classified according to planned enrolment, funding, status and geographical location, and we determined whether studies studied the originally approved indication. RESULTS:Overall, 69 novel drugs approved between 2005 and 2010 were eligible for inclusion. A total of 6679 relevant postmarketing studies were identifi

SUBMITTER: Zeitoun JD 

PROVIDER: S-EPMC5778291 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature