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The clinical value of FDA class C drugs approved from 1981 to 1988.
Yasuda SU, Woosley RL. Yasuda SU, et al. Clin Pharmacol Ther. 1992 Dec;52(6):577-82. doi: 10.1038/clpt.1992.194. Clin Pharmacol Ther. 1992. PMID: 1458766 No abstract available.
Regulating manufacturer-affiliated communication in the information age.
Schulman KA, Abernethy DR, Rathore SS, Woosley RL. Schulman KA, et al. Clin Pharmacol Ther. 1999 Jun;65(6):593-7. doi: 10.1016/S0009-9236(99)90080-2. Clin Pharmacol Ther. 1999. PMID: 10391664 No abstract available.
Research at the interface of industry, academia and regulatory science.
Mattes WB, Walker EG, Abadie E, Sistare FD, Vonderscher J, Woodcock J, Woosley RL. Mattes WB, et al. Nat Biotechnol. 2010 May;28(5):432-3. doi: 10.1038/nbt0510-432. Nat Biotechnol. 2010. PMID: 20458309 No abstract available.
They are from the government and they really are here to help you.
Woosley RL. Woosley RL. J Clin Pharmacol. 2008 Feb;48(2):142-3. doi: 10.1177/0091270007313559. J Clin Pharmacol. 2008. PMID: 18199889 No abstract available.
The translational path includes the FDA's critical path.
Woosley RL. Woosley RL. J Cardiovasc Transl Res. 2008 Sep;1(3):188-9. doi: 10.1007/s12265-008-9043-z. Epub 2008 Aug 11. J Cardiovasc Transl Res. 2008. PMID: 20559915 No abstract available.
Regulatory and reimbursement innovation.
Lindor RA, Allocco SJ, Cheatham L, Cortese DA, Hall RF, Mangold WJ Jr, Pizziconi V, Poste G, Quinn B, Roth M, Saks MJ, Wassman ER, Woosley RL, Marchant GE. Lindor RA, et al. Sci Transl Med. 2013 Mar 13;5(176):176cm3. doi: 10.1126/scitranslmed.3005437. Sci Transl Med. 2013. PMID: 23486776
One hundred years of drug regulation: where do we go from here?
Woosley RL. Woosley RL. Annu Rev Pharmacol Toxicol. 2013;53:255-73. doi: 10.1146/annurev-pharmtox-011112-140159. Epub 2012 Oct 16. Annu Rev Pharmacol Toxicol. 2013. PMID: 23072378 Review.
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