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On July 25, 2013, at 1:30PM (ET), FDA will present a webinar on a new draft guidance entitled "Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability."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Draft Guidance for Industry: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/ GuidanceComplianceRegulatoryIn formation/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.
Draft Guidance for Industry:
http://www.fda.gov/downloads/
FR Notice:
http://www.gpo.gov/fdsys/pkg/
For more information please visit: FDA HIV Webinar.
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