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FDA Oversight of Postmarketing Studies.
Kashoki M, Lee C, Stein P. Kashoki M, et al. Among authors: stein p. N Engl J Med. 2017 Sep 21;377(12):1201-1202. doi: 10.1056/NEJMc1709185. N Engl J Med. 2017. PMID: 28930501 Free article. No abstract available.
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Schuck RN, et al. Among authors: stein p. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Clin Pharmacol Ther. 2018. PMID: 29473145 Free PMC article. Review.
Breakthrough-Therapy Designation - An FDA Perspective.
Corrigan-Curay J, McKee AE, Stein P. Corrigan-Curay J, et al. Among authors: stein p. N Engl J Med. 2018 Apr 12;378(15):1457-1458. doi: 10.1056/NEJMc1801222. N Engl J Med. 2018. PMID: 29641963 Free article. No abstract available.
Clarifications regarding the authority and role of FDA in drug approval.
Cavaillé-Coll MW, Stein PP, Corrigan-Curay JA. Cavaillé-Coll MW, et al. Among authors: stein pp. Am J Transplant. 2020 Apr;20(4):1210-1211. doi: 10.1111/ajt.15734. Epub 2020 Jan 7. Am J Transplant. 2020. PMID: 31811778 Free article. No abstract available.
Integrated Drug Reviews at the US Food and Drug Administration.
Woodcock J, Stein P, Bugin K. Woodcock J, et al. Among authors: stein p. JAMA Intern Med. 2020 Sep 1;180(9):1248-1250. doi: 10.1001/jamainternmed.2020.1981. JAMA Intern Med. 2020. PMID: 32730618 No abstract available.
Randomized, observational, interventional, and real-world-What's in a name?
Concato J, Stein P, Dal Pan GJ, Ball R, Corrigan-Curay J. Concato J, et al. Among authors: stein p. Pharmacoepidemiol Drug Saf. 2020 Nov;29(11):1514-1517. doi: 10.1002/pds.5123. Epub 2020 Sep 17. Pharmacoepidemiol Drug Saf. 2020. PMID: 32940401 No abstract available.
1,509 results