DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.
EDITION PUBLISHED: APRIL 26, 2013
SECTION 1: FDA GUIDANCES
April 23, FDA announced the availability of a draft guidance document for industry entitled, “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” This draft guidance is intended to aid prescription drug and biologic manufacturers in minimizing medication errors by focusing on safety aspects of the container label and carton labeling design. The 60 day comment period will close June 22, 2013. [Draft Guidance] (FDA.gov)
April 23, FDA announced the availability of a draft guidance document entitled, “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’” This draft guidance is intended to aid sponsors in determining the potential toxicity of medical devices contacting the skin, clarify the Office of Device Evaluation General Program Memorandum #G95-1, and replace the memorandum when made final. [Draft Guidance] [FR Notice]
April 25, FDA announced the availability of a final guidance document entitled, “Assay Migration Studies for In Vitro Diagnostic Devices.” This guidance document is intended to provide a least burdensome approach to earn FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when an already approved assay is transitioning to a new system. [Guidance]
April 25, FDA also announced the availability of a final guidance document for industry entitled, “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance document is intended to aid sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) by informing them of the type of data that should be submitted to support the application. [Guidance] Note: the link appears to be temporarily unavailable as of 4/25/13. (FDA.gov)
For complete update, please visit http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
