An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences

What Are The Respective Roles Of The Public And Private Sectors In Pharmaceutical Innovation?

(2011) Bhaven N. Sampat et al.   HEALTH AFFAIRS

Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer

(2011) Aaron S. Kesselheim   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

“Pay for Delay” Settlements of Disputes over Pharmaceutical Patents

(2011) Aaron S. Kesselheim et al.   NEW ENGLAND JOURNAL OF MEDICINE

The Role of Public-Sector Research in the Discovery of Drugs and Vaccines

(2011) Ashley J. Stevens et al.   NEW ENGLAND JOURNAL OF MEDICINE

Characteristics of orphan drug applications that fail to achieve marketing approval in the USA

(2010) Harald E. Heemstra et al.   DRUG DISCOVERY TODAY

Safety-Related Regulatory Actions for Orphan Drugs in the US and EU

(2010) Harald E. Heemstra et al.   DRUG SAFETY

State Generic Substitution Laws Can Lower Drug Outlays Under Medicaid

(2010) William H. Shrank et al.   HEALTH AFFAIRS

Review of Oncology and Hematology Drug Product Approvals at the US Food and Drug Administration Between July 2005 and December 2007

(2010) R. Sridhara et al.   JNCI-Journal of the National Cancer Institute

Using Market-Exclusivity Incentives to Promote Pharmaceutical Innovation

(2010) Aaron S. Kesselheim   NEW ENGLAND JOURNAL OF MEDICINE

Market Exclusivity for Biologics

(2010)   NEW ENGLAND JOURNAL OF MEDICINE

Pivotal studies of orphan drugs approved for neurological diseases

(2009) Jun Mitsumoto et al.   ANNALS OF NEUROLOGY

Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

(2009) Barbara M Davit et al.   ANNALS OF PHARMACOTHERAPY

Orphan drug development is not taking off

(2009) Roberta Joppi et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Translation of rare disease research into orphan drug development: disease matters

(2009) Harald E. Heemstra et al.   DRUG DISCOVERY TODAY

The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?

(2009) Olivier Wellman-Labadie et al.   HEALTH POLICY

R&D policy, agency costs and innovation in personalized medicine

(2009) Wesley Yin   JOURNAL OF HEALTH ECONOMICS

Orphan products: an emerging trend in drug approvals

(2009) Timothy Coté et al.   NATURE REVIEWS DRUG DISCOVERY

Balancing Innovation and Access: Patent Challenges Tip the Scales

(2009) M. J. Higgins et al.   SCIENCE

The economic returns of pediatric clinical trials of antihypertensive drugs

(2008) Carissa M. Baker-Smith et al.   AMERICAN HEART JOURNAL

Academic Patents and Access to Medicines in Developing Countries

(2008) Bhaven N. Sampat   AMERICAN JOURNAL OF PUBLIC HEALTH

The economics of pediatric formulation development for off-patent drugs

(2008) Christopher-Paul Milne et al.   CLINICAL THERAPEUTICS

Clinical and economic burden of antimicrobial resistance

(2008) Lisa L Maragakis et al.   Expert Review of Anti-Infective Therapy

Pediatric Antihypertensive Trial Failures

(2008) Daniel K. Benjamin et al.   HYPERTENSION

Market incentives and pharmaceutical innovation

(2008) Wesley Yin   JOURNAL OF HEALTH ECONOMICS

Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers

(2008) Aaron S. Kesselheim   NEW ENGLAND JOURNAL OF MEDICINE

Incentives for orphan drug research and development in the United States

(2008) Enrique Seoane-Vazquez et al.   Orphanet Journal of Rare Diseases

Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity

(2008) P. B. Smith et al.   PEDIATRICS

Improving Pediatric Dosing Through Pediatric Initiatives: What We Have Learned

(2008) W. Rodriguez et al.   PEDIATRICS

Prioritizing Future Research on Off-Label Prescribing: Results of a Quantitative Evaluation

(2008) Surrey M Walton et al.   PHARMACOTHERAPY

Is Bayh-Dole Good for Developing Countries? Lessons from the US Experience

(2008) Anthony D So et al.   PLOS BIOLOGY

The Epidemic of Antibiotic-Resistant Infections: A Call to Action for the Medical Community from the Infectious Diseases Society of America

(2007) B. Spellberg et al.   CLINICAL INFECTIOUS DISEASES