miércoles, 24 de julio de 2013

Drug Information Update- July 25 webinar: Draft Guidance: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

On July 25, 2013, at 1:30PM (ET), FDA will present a webinar on a new draft guidance entitled "Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability."
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. However, all comments should also be submitted to docket so that they can be formally processed by FDA.

Draft Guidance for Industry:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf

FR Notice:
http://www.gpo.gov/fdsys/pkg/FR-2013-06-05/pdf/2013-13288.pdf

For more information please visit: FDA HIV Webinar.

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