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

Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?

(2012) J Woodcock   CLINICAL PHARMACOLOGY & THERAPEUTICS

Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

(2012) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

European Perspective on Risk Management and Drug Safety

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

Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug response

(2011) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY

Developing the Sentinel System — A National Resource for Evidence Development

(2011) Rachel E. Behrman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Getting to grips with the new European Union pharmacovigilance legislation

(2011) Patrick Waller   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

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

Why Drug Safety Should Not Take a Back Seat to Efficacy

(2011)   PLOS MEDICINE

Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration

(2010) Janet Woodcock et al.   NEW ENGLAND JOURNAL OF MEDICINE

Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

(2010) Preciosa M. Coloma et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Safe Drugs and the Cost of Good Intentions

(2009) Hans-Georg Eichler et al.   NEW ENGLAND JOURNAL OF MEDICINE

Managing Drug-Risk Information — What to Do with All Those New Numbers

(2009) Jerry Avorn et al.   NEW ENGLAND JOURNAL OF MEDICINE

Early Access to New Medicines

(2008) A Breckenridge et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Benefits and Risks of Drug Treatments

(2008) Jan P. Vandenbroucke et al.   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