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Items: 15

1.

Flexibility in the FDA approach to orphan drug development.

Hunter NL, Rao GR, Sherman RE.

Nat Rev Drug Discov. 2017 Nov;16(11):737-738. doi: 10.1038/nrd.2017.151. Epub 2017 Sep 1. No abstract available.

PMID:
28860647
2.

Combination products: modernizing the regulatory paradigm.

Hunter NL, Sherman RE.

Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12.

PMID:
28496147
3.

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM.

Nat Rev Drug Discov. 2017 May;16(5):297-298. doi: 10.1038/nrd.2017.25. Epub 2017 Feb 24.

PMID:
28232726
4.

Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration.

Rappel MJ, Hunter NL, Alexandrow AI, Hair KO, Sherman RE, Califf RM.

Clin Transl Sci. 2017 May;10(3):124-127. doi: 10.1111/cts.12441. Epub 2017 Feb 14. No abstract available.

5.

Real-World Evidence - What Is It and What Can It Tell Us?

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM.

N Engl J Med. 2016 Dec 8;375(23):2293-2297. No abstract available.

PMID:
27959688
6.

Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration.

Hunter NL, O'Callaghan KM, Califf RM.

JAMA. 2015 Dec 15;314(23):2499-500. doi: 10.1001/jama.2015.15818. No abstract available.

PMID:
26584067
7.
8.

Hindbrain rhombic lip is comprised of discrete progenitor cell populations allocated by Pax6.

Landsberg RL, Awatramani RB, Hunter NL, Farago AF, DiPietrantonio HJ, Rodriguez CI, Dymecki SM.

Neuron. 2005 Dec 22;48(6):933-47.

10.

Personal narratives of illness in schizophrenia: associations with neurocognition and symptoms.

Lysaker PH, France CM, Hunter NL, Davis LW.

Psychiatry. 2005;68(2):140-51.

PMID:
16247857
11.

Personal narratives in schizophrenia: increases in coherence following 5 months of vocational rehabilitation.

Lysaker PH, Davis LW, Hunter NL, Nees MA, Wickett A.

Psychiatr Rehabil J. 2005 Summer;29(1):66-8.

PMID:
16075701
12.

Ligand-activated Flpe for temporally regulated gene modifications.

Hunter NL, Awatramani RB, Farley FW, Dymecki SM.

Genesis. 2005 Mar;41(3):99-109.

PMID:
15729687
13.

Neurocognitive, social and clinical correlates of two domains of hopelessness in schizophrenia.

Lysaker PH, Davis LW, Hunter NL.

Schizophr Res. 2004 Oct 1;70(2-3):277-85.

PMID:
15329303
14.

Hopelessness as a predictor of work functioning among patients with schizophrenia.

Davis LW, Nees MA, Hunter NL, Lysaker PH.

Psychiatr Serv. 2004 Apr;55(4):434-6.

PMID:
15067157
15.

The first cervical vertebra: a plausible parameter for use in forensic identification?

Farman AG, Haskell B, Hunter NL.

J Forensic Odontostomatol. 1984 Jan-Jun;2(1):1-8. No abstract available.

PMID:
6599794

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