The investigational new drug applicatio... [Nat Clin Pract Oncol. 2006] - PubMed

IRBs and the new rule on research with children. [Hum Res Rep. 2002]
IRBs and the new rule on research with children.
Maloney DM. Hum Res Rep. 2002 Jan; 17(1):4.
Why wasn't an investigational new drug (IND) application required before appropriate study? [Hum Res Rep. 2004]
Why wasn't an investigational new drug (IND) application required before appropriate study?
Maloney DM. Hum Res Rep. 2004 Mar; 19(3):6-7.
Protecting subjects without hampering research progress: guidance from the office for human research protections. [Cleve Clin J Med. 2007]
Protecting subjects without hampering research progress: guidance from the office for human research protections.
Schwetz BA. Cleve Clin J Med. 2007 Mar; 74 Suppl 2:S60-2; discussion S68-9.
Review Research involving children: regulations, review boards and reform. [J Health Care Law Policy. 2005]
Review Research involving children: regulations, review boards and reform.
Gandhi R. J Health Care Law Policy. 2005; 8(2):264-330.
Review Inconsistent regulatory protection under the U.S. Common Rule. [Camb Q Healthc Ethics. 2004]
Review Inconsistent regulatory protection under the U.S. Common Rule.
Evans BJ. Camb Q Healthc Ethics. 2004 Fall; 13(4):366-79.

Should terminally ill patients have the right to take drugs that pass phase I testing? Yes. [BMJ. 2007]
Should terminally ill patients have the right to take drugs that pass phase I testing? Yes.
Freireich EJ. BMJ. 2007 Sep 8; 335(7618):478.

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