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Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe

(2010) W P C Boon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

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

A Decade of Safety-Related Regulatory Action in the Netherlands

(2010) Peter G.M. Mol et al.   DRUG SAFETY

New drug approval success rate in Europe in 2009

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Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?

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Balancing Drug Risk and Benefit: Toward Refining the Process of FDA Decisions Affecting Patient Care

(2008) Lawrence R. Schiller et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Perifollicular Xanthomatosis as the Hallmark of Axillary Fox-Fordyce Disease

(2008) Adolfo B. Bormate et al.   ARCHIVES OF DERMATOLOGY

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

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

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Drug-Review Deadlines and Safety Problems

(2008) Daniel Carpenter et al.   NEW ENGLAND JOURNAL OF MEDICINE