SPONSORED ARTICLE REGULATORY
now dealing with issues either ahead of or behind the US schedule. We have learned from developments abroad that are not yet fully the reality in the US, e.g., comparative effectiveness, and we worry about markets where the problems resemble those confronted in the US in the last century. It is also instructive to see how cultural forces affect policy choices, and increasing harmonization makes attentiveness to ex-US developments imperative. GJ: Although I get on a plane less than Coleen and Ray, I echo her sentiments. In the clinical trial space, as our clients increasingly conduct clinical trials globally, we are forced to think globally and it is imperative that we help them learn the rules in different jurisdictions. A good example of this is human subject protection rules, as different countries have taken different approaches to implementing the Declaration of Helsinki; for example, with respect to whether the Sponsor must make study drugs available to subjects at the conclusion of a trial, or whether and to what extent subjects may be compensated for participation.
How does the FDA regulatory practice communicate with Sidley’s very well-known investigations practice? Why is it important to have such capabilities?
leagues in the white-collar practice and others who are more litigators than regulatory lawyers are important consumers of our services, and we strive to provide them, as well as our clients, with business-sensitive, sophisticated, right-sized, timely advice on all of their matters. Investigations benefit greatly from regulatory input because regulatory lawyers are the principal r W?6?F?&?W2?bW?W&?V?6R??F?R7V6?f?27FGWF?'?66?V?RF?B7&VFW2F?R?FV?F???&??G?F?B??GW&?gV?7F???22F?Rg&?Wv?&?f?"F?R??fW7F?vF????vRF?W&Vf?&Rf?7W2??????r7W&RF?R&?6V7WF?'2&V6?FRF?R??FF???2??F?RWF??&?F?W2F?W???&R&V???r??2?WfW&vR??6WGF?V?V?BF?67W76???2?f?"W???R?vR?fR???6??6W2F?F?F???R??F?W"?BF?7Ffb?GFW'27&?72F?66???W2?vRF?&VwV?&?7&?72FV?2?B?W&?6F?7F???2F???R7W&RWfW'???R?2vV????f?&?VB?Bv?&???rVffV7F?fV?F?vWF?W"?t???W?W&?V?6RBF?Rf?&??26??v??RF?BF?W&R?2??B?bv&V?W72??v?BvRF??F??2&V???27&?F?6???F?RvV?WF?7276S?F?W&R&R6WfW&??666???2F?B??fRv?&?VBv?F??V?F?6&R?w?W'2??7&?72?7WGF??r?77VW2??F?R&V2?bF?v??7F?72?vR?fR&VV?&?RF?v?&?fW'?VffV7F?fV?2FV?f?"6?V?G2F?F????&?WB?Wr'W6??W72??FV?2F?66???6?F?v??7F?2FW7F??r?( ??F?R6???6?G&??76R?2?W"6?V?G2??7&V6??v?6??GV7B6???6?G&??2v??&???vR&Rf?&6VBF?F????v??&???B?B?2??W&F?fRF?BvR?V?F?V??V&?F?R'V?W2??F?ffW&V?B?W&?6F?7F???2?v??BW???R?bF??2?2?V??7V&?V7B&?FV7F???'V?W2?2F?ffW&V?B6?V?G&?W2?fRF?V?F?ffW&V?B&?6?W2F????V?V?F??rF?RFV6?&F????b?V?6???( ??F???R?fR??Gf?6Rf?"4??vR6W'F???F??W"&W7BF?&R?&2???V?r76?6?FRv?&???r??6F?'2??&V??b?bF?R&VwV?F?'?&7F?6RF??276S????FW&????6?F?W?( ?2dD&7F?6R7F'FVB?WB2?V?f?&6V?V?Bw&?W?BF?R?FV?bgV???6W'f?6R&VwV?F?'??rFV?v26??Wv?B?Wr?'B?bF?R6???V?vR?2????r7W&RWfW'?&?G????w2v?BWfW'???RV?6R?2F???r?B?26&?R?bF???r?vR?fRF?7F??7B6W&FR&7F?6W2?????&V2?bF?R??GW7G'??vR?fR&7F?6RFWf?FVBF?6V?FW'2f?"?VF?6&Rb?VF?6?B6W'f?6W2?4?2?v?&?F?B?26W&FRg&???W"f??B?G'Vr?B?VF?6?FWf?6R&VwV?F?'?&7F?6R&VFV??f?"W???R??W"6??4???Gf?6Rv?V?B&RF?66WBF?Bf??B?BG'Vr?rv??????vWB??&R6???W??BF?B??R?WfW"7F??V&???r?BV?6?V?FW&??r?Wr6???V?vW2?????R?2WfW'?F???r6???WFV?6?fW&VB?BV?FW'7F??B??B?B?2???'F?B?v?2F?6VV???'GV??F?W2F??V&?g&??F?R6?W'G2?B6??w&W72?Bg&??F?RdD?G6V?b???FV??V7GV??V??G??2F?R??7B???'F?B??w&VF?V?BF?7V66W72??F??2&7F?6R?t??f?'7B??WfW"&R6??VBF?6?VW7F???>( F?b6?W'6RF?2?V6?&W6V&6?0????R6??'WBF?W&^( ?2??7V'7F?GWFRf?"??7F?GWF???????v?VFvR?B?V??'???F??2f?V?B?6V6??B?&R67W&FR???R?bF?Rf?'7B'F?W'2?v?&?VBf?"2??V?r76?6?FRBF?ffW&V?Bf?&?v2?'6W76?fR&?WB6????7F?W2???6?VF??rG??2?B6?FF???2?6?R6?BF?B?b??RvWBF?R6???F???w2w&??r?V??Rv?????BG'W7B??W"7V'7F?F?fRGf?6R??Bv2F?Vv??W76???'WB??R??fR6'&?VBv?F??R???&7F?6R?f??????v?2&VBF?R&V?&?R?F?dD'V?V????u????f66??F??r?VvvWG26?&Rf?V?BF?W&V???4???BF??( ?Bf?&vWBF?V????F?Rf?'7Bf??B?BG'Vr?r66V&?????F???v??F?W72f?"F?V??????r?dR44?T?4U2#0????