„… Genetically Modified Crops and Their Products in the United States: A Review of the Regulatory …” „… trial chemicals, which raise additional regulatory issues. Though transgenic animals are not the fo cus …” „… A rticle provides an overview o f the regulatory system that governs authorization o f GM …”

„… Pharmaceutical Regulatory Process, 47-71, 1. Auflage 2005, New York (zitiert als: Peskoe, Drug-Approval Before …” „… Right to Access Experimental Drugs Pending Final FDA Approval – Abigail Alliance v. von Eschenbach, 445 …” „… Agency, in: Berry, Ira R., The Pharmaceutical Regulatory Process, 220-225, 1. Auflage 2005, New York …”

„… . 1984). 1176 Niioka, klinische Versuche im Patentrecht, 78; Cook, Protection of Regulatory Data, 78 …” „… ; Fox/Bennett, History of Waxman-Hatch Act, 2; Guarino, ANDAs and SNDAs, 173; Rosen, Generic Drug Approval Pre …” „… Rosen, Generic Drug Approval Pre-1984, 103. 1192 Guarino, ANDAs and SNDAs, 173; Fox/Bennett, History of …”

„… structures by extending the requirement for rate approval by the regulatory authority to cover new rates as …” „… 99 Reduction of Regulatory Risk: A Network Economic Approach Günter Knieps und Hans-Jörg Weiß 1 …” „… Alternative Definitions of Regulatory Risk According to Kolbe, Tye, and Myers (1993, p. 33), “there appears …”

„… (No) market for corporate governance? Related party transactions and shareholder approval rights …” „… . Contrast for example the French or the United Kingdom’s rules on transparency and on shareholder approval …” „… that issue. The company must wait for approval or else conclude the transaction under the condition of …”

„… outside clinical trials. Thus, appropriate measures should be implemented to close regulatory loopholes …” „… involves both in vitro and in vivo animal model studies.15 The approval of a health product for a clinical …” „… regulatory framework for human cellular and tissue products prohibits the clinical use of PSCs/IPSCs outside …”

„… (please see Yano (et. al.), Regulatory approval for autologous human cells and tissue products in the …” „… potential for future therapies, need a clear regulatory framework. 1 New tools for disease research …” „… iPS cell-based therapies and the regulatory landscape in both countries. iPS cells vs. iPS cell-based …”

„… some regulatory issues regarding the individual aspect of autologous use of these cells8, such …” „… , Cell 2006, 663. 8 Carpenter/Couture, Regulatory considerations for the development of autologous …” „… , Regulatory considerations for the development of autologous induced pluripotent stem cell therapies …”

„… , but also plants, animals, and even artificial genomes. A balanced regulatory framework will be …” „… led to the first FDA approval of a gene therapy against Leber congenital amaurosis or retinitis …”