This webinar,intended to encourage the submission of questions or comments while the guidance is still in draft form, will provide an opportunity to learn about the guidance from individuals involved in its preparation.
Questions may be submitted online during the webinar and will be addressed as time permits. All comments should also be submitted to docket so that they can be formally processed by FDA.
DRAFT Guidance
http://www.fda.gov/downloads/
Federal Register Notice
http://www.gpo.gov/fdsys/pkg/
The Comment Period Will Close on 08/09/2013.
Please plan to join. Your comments are important.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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