Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe

The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology’s Success

(2014) R P Evens et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

(2014) Peter Arlett et al.   NATURE REVIEWS DRUG DISCOVERY

Differences Between Post-Authorization Adverse Drug Reactions of Biopharmaceuticals and Small Molecules

(2013) Hans C. Ebbers et al.   BIODRUGS

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

(2013) Niels S. Vermeer et al.   DRUG SAFETY

From molecule to market access: Drug regulatory science as an upcoming discipline

(2013) Christine C. Gispen-de Wied et al.   EUROPEAN JOURNAL OF PHARMACOLOGY

The risks of risk aversion in drug regulation

(2013) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

(2013) Ruben G. Duijnhoven et al.   PLOS MEDICINE

Safety Learning From Drugs of the Same Class: Room for Improvement

(2012) G Stefansdottir et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Risk Minimization Activities of Centrally Authorized Products in the EU

(2012) Inge M. Zomerdijk et al.   DRUG SAFETY

European Perspective on Risk Management and Drug Safety

(2011) J Raine et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Efficient drug approval and monitoring must rely on sound regulatory science

(2011) Emma A Meagher et al.   NATURE MEDICINE

European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

(2011) Kevin V. Blake et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Risk Management Plans: are they a tool for improving drug safety?

(2010) Serena Frau et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Biopharmaceutical benchmarks 2010

(2010) Gary Walsh   NATURE BIOTECHNOLOGY

Does diabetes therapy influence the risk of cancer?

(2009) U. Smith et al.   DIABETOLOGIA

Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval

(2009) Thijs J. Giezen et al.   DRUG SAFETY

Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union

(2008)   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

(2008) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY