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Jan 14 2011

FDA Guidances – December 2010

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 December 2010, including a few from the first week of January 2011 as well (links go directly to PDF documents).

Special Interest Guidances/Information Date Posted

Electronic Source Documentation in Clinical Investigations (Draft)

1/06/2011

Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination (Draft)

12/14/2010

Other Recent Guidances Date Posted
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (Draft) (Revises the draft guidance of the same title published in December 2008)

1/2011

Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) (Draft)

01/05/11

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi (Draft)

01/05/11

“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV.

12/30/2010

Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

12/2010

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile (Draft)

11/29/10

Blood Lancet Labeling

11/29/10