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Dec 15 2010

FDA Guidances – November 2010

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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 November 2010 (links go directly to PDF documents).

Special Interest Guidances/Information Date Posted
Specifications for eCTD Validation Criteria v. 2.0 (Draft) 12/10/2010
Other Recent Guidances Date Posted
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion 12/06/2010
Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application 12/03/2010
Blood Lancet Labeling 11/29/2010
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile (Draft) 11/29/2010
ANDAs:  Impurities in Drug Products 11/26/2010
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia:  Developing Drugs for Treatment (Draft) 11/26/2010
Antibacterial Drug Products:  Use of Noninferiority Trials to Support Approval (Draft) 11/26/2010
MQSA Inspectors and FDA Staff – The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 11/16/2010
Dear Health Care Provider Letters:Improving Communication of Important Safety Information (Draft) 11/15/2010
Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) 11/10/10
Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin 11/10/10
Class II Special Controls Guidance Document: Full Field Digital Mammography System 11/05/10
Cellular Therapy for Cardiac Disease 11/04/10