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From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Among authors: tunis s. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
Accelerated access to innovative medicines for patients in need.
Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Baird LG, et al. Among authors: tunis s. Clin Pharmacol Ther. 2014 Nov;96(5):559-71. doi: 10.1038/clpt.2014.145. Epub 2014 Jul 9. Clin Pharmacol Ther. 2014. PMID: 25006877
Current and future state of FDA-CMS parallel reviews.
Messner DA, Tunis SR. Messner DA, et al. Among authors: tunis sr. Clin Pharmacol Ther. 2012 Mar;91(3):383-5. doi: 10.1038/clpt.2011.350. Clin Pharmacol Ther. 2012. PMID: 22343814
187 results