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4 in total

1. Safety-related regulatory actions for biologicals approved in the United States and the European Union.

Authors: Thijs J Giezen; Aukje K Mantel-Teeuwisse; Sabine M J M Straus; Huub Schellekens; Hubert G M Leufkens; Antoine C G Egberts
Journal: JAMA Date: 2008-10-22 Impact factor: 56.272

2. Regulation--the real threat to clinical research.

Authors: Paul M Stewart; Anna Stears; Jeremy W Tomlinson; Morris J Brown
Journal: BMJ Date: 2008-10-16

Review 3. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Authors: Hans-Georg Eichler; Francesco Pignatti; Bruno Flamion; Hubert Leufkens; Alasdair Breckenridge
Journal: Nat Rev Drug Discov Date: 2008-09-12 Impact factor: 84.694

4. Medicine. Life cycle of translational research for medical interventions.

Authors: Despina G Contopoulos-Ioannidis; George A Alexiou; Theodore C Gouvias; John P A Ioannidis
Journal: Science Date: 2008-09-05 Impact factor: 47.728

4 in total

3 in total

The good, the bad and the ugly red tape of biomedical research. How could regulators lower bureaucratic hurdles in clinical research without compromising the safety of patients?

1. Safety-related regulatory actions for biologicals approved in the United States and the European Union.

2. Regulation--the real threat to clinical research.

Review 3. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

4. Medicine. Life cycle of translational research for medical interventions.

1. Mapping the translational science policy 'valley of death'.

2. The 'molecularly unstratified' patient: a focus for moral, psycho-social and societal research.

3. Modernising the regulation of medical migration: moving from national monopolies to international markets.