domingo, 10 de diciembre de 2017

New Workshops: IND Safety Reporting/ Oncology Precision Medicine/ Medical Gas Regulation

1. Medical Gas Regulation; Public Workshops; Request for Comments
FDA is announcing two public workshops entitled ‘‘Medical Gas Regulation: Workshop I’’ and ‘‘Medical Gas Regulation: Workshop II.’’ The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.
The first public workshop will be held on December 15, 2017, from 9 a.m. to 5 p.m. The second public workshop will  be held on February 9, 2018, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the workshops may end early. FDA may announce additional public workshop dates in the future, if needed.
2. Safety Assessment for IND Safety Reporting – Public Workshop
Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of this public workshop is to bring the stakeholder community together to discuss a variety of topics related to ‘‘Safety Assessment for Investigational New Drug (IND) Safety Reporting.’’ The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled ‘‘Safety Assessment for IND Safety Reporting.’’ The workshop will be held on January 11, 2018 in Washington D.C.
3. Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop
The purpose of the public workshop is to engage stakeholders and solicit input from experts in oncology precision medicine on how to best weigh and evaluate evidence for classification and interpretation of sequencing results for precision oncology. The public workshop will be held on January 29, 2018 in Silver Spring, MD.

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