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FDA Establishes New Public Docket

Thu, Jun 10, 2010

Clinical News Room

The Food and Drug Administration (FDA) is establishing a public docket to obtain input on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development.

To read the full Federal Register notice please click on the following link: http://edocket.access.gpo.gov/2010/pdf/2010-13769.pdf

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