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Monday, March 22, 2010

Clinical Trials

Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (October 13, 2009)
BIO comments to the FDA (75 KB PDF)

Expansion of the Clinical Trial Registry and Results Data Bank (June 22, 2009)
BIO comments to the NIH (222 KB PDF)

BIO's Position Statement on Clinical Trials Registries and Dissemination of Results (June 21, 2005)
Read the statement.

BIO's Comments to FDA's Proposed Rule on Institutional Review Board (IRB) Registration Requirements (September 27, 2004)
Docket No. 2004N-0242, Federal Register: July 6, 2004 (Volume 69, Number 128, pp. 40556-40562). Read the comments. (100 KB PDF)

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