July 2010 FDA Guidances

Posted on 9 August 2010 by Ask-Cato.com Contributor

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Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in July 2010 (links go directly to PDF documents).

Special Interest Guidances/Information	Date Posted
Residual Drug in Transdermal and Related Drug Delivery Systems *(Draft)*	8/02/2010
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application	7/30/2010
Humanitarian Device Exemption (HDE) Regulation: Questions and Answers	7/08/2010
Other Recent Guidances	Date Posted
General Considerations for Animal Studies for Cardiovascular Devices	7/29/2010
ICH Q3C Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents *(Draft)*	7/19/2010
ICH Q4B Annex 14: Bacterial Endotoxins Test *(Draft)* Annex 13: Bulk Density and Tapped Density of Powders *(Draft)*	7/16/2010 7/13/2010

This entry was posted in FDA, Regulatory Strategy and tagged cardiovascular, FDA, guidance, ICH, IND, medical devices, nonclinical research, transdermal. Bookmark the permalink.

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