Regulatory watch: Outcomes of EMA marketing authorization applications: does partnering have an influence?
1] Utrecht Institute of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, P.O. Box 80082, 3508 TB Utrecht, The Netherlands. [2] National Institute for Public Health and the Environment, Division of Nutrition, Medicines and Consumer Safety, P.O. Box 13720, BA Bilthoven, The Netherlands.
Cornelis A
CA
van den Bogert
Utrecht Institute of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, P.O. Box 80082, 3508 TB Utrecht, The Netherlands.
Patrick C
PC
Souverein
Utrecht Institute of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, P.O. Box 80082, 3508 TB Utrecht, The Netherlands.
Michelle
M
Putzeist
Utrecht Institute of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, P.O. Box 80082, 3508 TB Utrecht, The Netherlands.
Hubert G M
HG
Leufkens
National Institute for Public Health and the Environment, Division of Nutrition, Medicines and Consumer Safety, P.O. Box 13720, BA Bilthoven, The Netherlands.
Susan W J
SW
Janssen
Central Committee on Research Involving Human Subjects, P.O. Box 16302, 2500 BH The Hague, The Netherlands.
Gerard H
GH
Koëter
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000639:trends*; D005060:Europe; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000639:trends*